Associate Clinical Resume Samples
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Associate Clinical Resume Samples
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HM
H Moen
Hellen
Moen
8774 Etha Grove
New York
NY
+1 (555) 770 8259
8774 Etha Grove
New York
NY
Phone
p
+1 (555) 770 8259
Experience
Experience
San Francisco, CA
Clinical Trials Associate
San Francisco, CA
Schaden and Sons
San Francisco, CA
Clinical Trials Associate
- Coordinates the packaging, shipping, and tracking of study supplies and materials
- Organizes and prepares study files related to study tracking and reporting and submits them to the Trial Master File within established guidelines
- May mentor more junior Clinical Operations Staff or participate in the on boarding of new personnel
- Maintains and tracks revisions to all documentation for accuracy, including patient Informed Consent Forms and Case Report Forms
- Assists the Clinical Project Manager in ensuring compliance with Clinical Study Protocol and provides timely updates to assigned Clinical Project Manager to confirm compliance
- Utilizes technology effectively to support clinical development processes; develops mastery of relevant systems (e.g. study management tools) and identifies new innovative ideas and shares best practices
- Demonstrates a working knowledge of ICH GCP regulations and clinical protocols
New York, NY
Clinical Subjects Associate
New York, NY
Lemke, Barrows and Corkery
New York, NY
Clinical Subjects Associate
- Provide back-up and coverage to other BMT data managers
- Work with lead coordinator and Project Manager on daily study activities and recruitment
- Work collaboratively with MADC and Neurology clinical trials teams
- Flexible work schedule
- Manage recruitment procedures, letters and phone calls to reach out to sites and potential participants
- Maintain own tracking sheet for assessing individual work duties
- Help identify sites and providers for COMPARE-UF study objectives
present
Boston, MA
Temp-clinical Trial Operations Associate
Boston, MA
Rolfson-Ferry
present
Boston, MA
Temp-clinical Trial Operations Associate
present
- Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and US FDA regulations
- Assists with vendor management
- Compiles and maintains regular status reports of study progress, and ensures information is provided to management
- Assists with and/or may play a lead role in the development of procedures and tools for data collection
- Assists CTM or project manager with requesting, collecting, and reviewing site regulatory documents
- Assists with and/or may play a lead role in the development of study documents including informed consent forms, data collection tools and procedure manuals
- May have site management responsibilities
Education
Education
Bachelor’s Degree in Social Science
Bachelor’s Degree in Social Science
Towson University
Bachelor’s Degree in Social Science
Skills
Skills
- Recruit and schedule research participants’ initial and follow-up appointments for supported studies of the MADC/ Michigan Alzheimer’s Disease Core Center, including the University of Michigan Memory and Aging Project, Decision Making for Cardiovascular Therapy in Adults with Mild Cognitive Impairment study; MADC research registry, and the Community Urban Electroencephalogram Study at the University of Michigan Detroit Center in Detroit
- Attend and recruit research participants from Health Fairs and community outreach events in Ann Arbor and surrounding areas including Detroit
- Conduct research related blood draws/saliva collection in Ann Arbor and Detroit which will include, but not limited to processing, quality control, labeling, storing, handling and shipping of specimens to repositories
- Maintain research appointments calendar
- Coordinate research participant room reservations at the MADC and the U-M Detroit Center in Detroit
- Administer paper/pencil and computerized neuropsychological examinations to research participants
- Write behavioral observations and score neuropsychological evaluations
- Enter electronic data into secure electronic data capture system database (REDCap)
- Administer 64 channel Electroencephalogram to research participants; upload data into a secure file
- Schedule and place MRI appointments and blood lab orders in electronic health records (MiChart)
15 Associate Clinical resume templates
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1
Associate Clinical Engineering Manager Resume Examples & Samples
- Coordinates the processing of ARAMARK’s vendor service contracts from field inception through approvals, purchase order release, annual renewals and expirations
- Reviews and approves Purchase Orders based on set approval authority
- Identifies opportunities to avoid cost associated with parts returns and exchanges; monitors trends
- Collaborates with all aspects of Supply Chain in developing and maintaining standards for supplier contract pricing, terms & conditions, and certifications
- Process vendor service contracts and review all applicable parameters of contract for accuracy in applicable supply chain database
- Understands, predicts, and enhances the supply chain processes and infrastructure
- Develops and implements purchasing policies, procedures, and methods to ensure proper vendors are utilized during purchasing
- Utilizes the defined purchasing methodology to purchase necessary goods and services
- The successful candidate will be highly organized; familiar with standard concepts, practices, and procedures pertaining to contract administration; have the experience and judgment to plan and accomplish goals and to prioritize and process for signature a significant volume of contract documents; and be able to multitask and work under general supervision to relieve managers of administrative detail associated with the contracting process
- Ability to interpret contractual documents and transfer data/knowledge into applicable supply chain database
- Negotiates all service supplier contracts, including renewals and new contract requests
- Handles supplier escalations for service delivery or service contract issues encountered at a national or local level
- Makes sound independent decisions to drive supplier delivery outcomes to the satisfaction of Supply Chain and executive-level management, as well as drive verifiable financial outcomes to meet and exceed the financial expectations of the business
- Manages incoming vendor service contract requests via I-desk including new agreements, renewals, addendums, and cancellations
- Paralegal experience strongly desired
- Minimum four year college degree or equivalent paralegal experience may be substituted
- An equivalent combination of education and experience may be substituted
- Knowledge of applicable trade areas
- Listening Skills
- The ability to combine pieces of information to form general rules or conclusions
- The ability to read and understand information and ideas presented in writing
- The ability to apply general rules to specific problems to produce answers that make sense
- Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems
2
Clinical Production Associate Resume Examples & Samples
- Ability to read and interpret documents such as safety procedures/rules and standard operating procedures (SOPs). Must be able to communicate effectively with other CCT functional areas, and accrediting and regulatory agencies
- Must have excellent organization skills and ability to handle multiple tasks
- Highly motivated, willingness to acquire new skills and ability to work with minimal supervision
- Must have strong engineering or scientific knowledge appropriate for processing clinical grade cellular therapeutics
- Ability to consistently perform various manual production duties and techniques on time sensitive material with accurate and precise manipulations. Example: performing cell separations or preparation of cryopreservation
- Knowledge of cGMPs and SOP development would be advantageous
- A basic knowledge in computer applications including basic MS Word and Excel required
- Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for extensive walking, standing and occasional lifting of heavy materials that have a weight of 30 - 40 lbs maximum. Frequent visual demands require macroscopic and microscopic observations
- Contractors must work in areas where posted Biological Universal Precautions must be observed and practiced. There is repeated contact with potential infectious blood products with subsequent risks of acquired infections. Associates work daily with potentially harmful and/or hazardous agents including asphyxiating gases (nitrogen), potentially carcinogenic and/or inflammable chemical reagents and sharps
- Execute/implement Clinical Production batch records for the following areas: cell culture, cell harvesting, tissue processing (placenta), cryopreservation
- Maintain and deliver sufficient supply of appropriate grade material for clinical studies in accordance with timelines, and participate in clinical supply campaigns
- Perform tasks in the absence of supervisor
- Coordinate daily laboratory tasks
- Contributes input toward the revision of Standard Operating Procedures (SOPs)
- Daily review of batch records
- Prepare and maintain cell culture reagents and media
- Ensure sufficient laboratory supplies for daily laboratory operations
- Ensure proper operation and perform routine maintenance of all laboratory equipment
- Assist other staff to complete tasks
- Follow SOP's associated with processing of Clinical Grade Cellular Therapeutics
- Responsible for entering processing data into Batch Records
- Proper handling and storage of products into designated freezer or liquid nitrogen tank
- Operation of laboratory processing equipment, including Biosafety Cabinets and Clean Rooms
- Maintain a clean and safe work environment in accordance with policies/procedures and OSHA safe practices
3
Associate Clinical Account Specialist Resume Examples & Samples
- The selected candidate will learn to provide education and training regarding BWI CARTO® 3-D electro-anatomical mapping system as well as other accessory equipment and will quickly become an extension of a collaborative field force and EP lab team
- Pivotal to their success will be their ability to develop the clinical and business acumen necessary to meet the procedure support needs of our customers while exceeding business objectives
- As available, after the initial development period, and demonstrated proficiency to work independently in the CAS role, meeting customers’ needs and exceeding business results, the ACAS will be assigned a territory of responsibility within a mutually agreed upon geography as a CAS
- During the training period, under the general direction of the manager and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will learn to
- A minimum of a related Bachelors Degree is required, Masters Degree preferred. Degree in Biomedical Engineering, Nursing or related degree preferred
- This position requires candidates to be one of the following: a graduate within the last 36 months from an accredited academic program, or accredited EP school, or exiting a branch of the US Military
- Candidates must possess a valid driver's license issued in the United States and must successfully complete a background investigation, to include a review of your driving record history
- Must be willing and able to travel up to 40% overnight locally, regionally, and nationally. Ability to relocate at the end of the training program
- Required to work in a laboratory setting near or with heavy equipment, ability to lift 60 lbs., and wear protective gear (i.e. lead aprons)
4
Associate Director, Duke Clinical Engagement Resume Examples & Samples
- Provide support and direction in the development and advancement of the Duke Clinical Engagement program. This entails building internal and external infrastructure, processes, and programs that enhance the ability of DUHS clinicians to engage with the clinicians at Duke LifePoint hospitals and communities
- Support and develop initiatives for the Duke Clinical Engagement program. This will require creativity and resourcefulness and will entail assessing various clinical sites for their strategic and clinical needs. It will require tailoring programs to site-specific needs. Regular consultation with affiliate leadership teams, providers, and front-line operations managers is required. Processes and interventions must be created while considering that all material must be evidence-based, data driven, sustainable and scalable. Many programs will be delivered remotely
- LifePoint Eastern Group Leadership team
- LifePoint Hospital Support Center
- Office of the General Counsel
- The Joint Commission Readiness team
- Regional Patient Safety Officers
- Quality team
- Risk and Compliance teams
- Work requires a minimum of five years management experience within the healthcare industry. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
- Work requires a minimum of five years related business or administrative experience in hospital or group practice operations, or management planning
- Experience in program development and/or project management is very strongly preferred
- Significant experience in operations management, quality improvement, use of metrics to manage and improve performance, clinical education, quality improvement, and patient safety, is very strongly preferred
- Experience with physician support and quality oversight is very strongly preferred
- A deep understanding of clinical processes and hospital operations
- Experience in professional development and/or education
- Experience in leading teams through process improvement and change initiatives
- Ability to motivate and sustain interest in improving patient safety and clinical quality
- Consultative skills required, experience strongly preferred
- Effective organizational, problem solving, program development, computer, strong leadership, and team building skills
- A proven track record of working effectively with all levels of staff
- Facilitation skills
- Ability to manage several projects and processes simultaneously utilizing project management software
- Ability to travel to affiliated sites (travel will be required)
- Must be willing to fly to sites on both commercial and private airplanes
5
CO Clinical Associate Resume Examples & Samples
- Provide and facilitate perioperative evaluation and care of patients, and ensure the provision of the highest quality care
- Provide anesthesiology services primarily at the Johns Hopkins Bayview Medical Centers
- Exercise medical judgment consistent with approved anesthesiology methods and practices and in the best interest of the patients
- Provide expert knowledge, skills, and clinical services in teaching of medical students and training of residents and supervision of CRNAs
6
Clinical Associate Manager Resume Examples & Samples
- A career centered in CNS clinical trials and Outcomes Research
- Ability to support a manager and delegate to direct reports
- Experience working with populations affected by Schizophrenia and/or depression
- Masters Degree or 3 years work relevant work experience
7
Clinical Trial Documentation Associate Resume Examples & Samples
- Supports the preparation and submission of appropriate documents to the Research Ethics Board for review and approval (e.g., Protocol, Investigators Brochures, Informed Consent Forms, Telephone screens, subject information sheets, and advertisements)
- Helps track the approval process and updates study team members on the approval status of all clinical trials
- Serves as the administrative support liaison with the Research Ethics Board for study-related submissions
- Submits revised and additional materials (e.g. amendments, advertisements, safety and study status updates, close out reports, etc.) as required
- Reviews and files approval documentation from the Research Ethics Board in the ISF and/or TMF and on the Study Specific Directory
- Helps to prepare an ISF and/or TMF for all studies and manages, along with clinic staff, the ongoing collection and filing of essential documents in the ISF and/or TMF
- Supports the Protocol and Protocol Amendment distribution process
- Supports the compilation, completion, and internal approval process of Regulatory documentation, (Qualified Investigator Undertaking, FDA 1572, Financial Disclosure, etc.) and provides completed Regulatory documentation to Sponsor/CRO for each study
- Supports and establishes an electronic file structure for each clinical trial for use by clinical study team members
8
Associate Clinical Resume Examples & Samples
- Day-to-day scheduling of clinical projects and assisting with commercial project scheduling as needed
- Driving schedules of client Raw material / Consumables inventory, orders, release, and delivery
- Assisting with internal and external equipment calibration & validation schedules
- Assisting with managing Audit Readiness in the Manufacturing areas. This role requires routine interaction and planning with QA Raw Materials, Logistics, Project Managers, and Purchasing
- Interacting with Engineering, Maintenance, Validation, Quality Assurance, Quality Control groups and materials/equipment vendors
- Contributes to the overall operations of the lab
- This role requires being current on Good Manufacturing Practices (cGMP) and having an understanding of the regulatory compliance requirements for the production of biologics used in clinical studies
- BS Degree w/ Science Major and 0 to 1 year of experience with understanding of Cell Processing required
- Ability to work effectively as part of a team
- Ability to learn to evaluate technical data and write technical documents
- Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations
- Ability to record data accurately and legibly
9
Clinical Trials Associate Resume Examples & Samples
- Independently manages multiple site level deliverables during start-up, maintenance and closure both within BMS and external business partners and vendors, when required
- Collaborates directly with the US clinical site staff to ensure management and alignment on BMS business processes and execution of study timelines
- Manages and makes decisions on the development and execution of study related binders at study start-up
- Drives the collection and review of site regulatory documentation directly from US sites in accordance to SOPs, GCP and regulatory guidelines
- Responsible for site level source documentation within the Clinical Trial Master File to ensure accuracy and completeness of the trial master file in preparation for audit and inspection
- Executes all appropriate business processes to ensure Clinical Trial Package completion for drug shipment in achieved
- Trains and develops US clinical site staff in the execution of regulatory documentation
- 5 years revelant work experience
- Knowledge of ICH/GCP Guidelines and local regulatory guidelines or regulations preferred
- Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalivent
- Bachelor’s degree in nursing, life science or healthcare related field, preferred
- Additional complex software application related to clinical trial research (i.e electronic data capture or patient diaries, interactive voice response, etc…)
- 1602628
10
Clinical Trial Management Associate Resume Examples & Samples
- Bachelors degree (scientific or health-related field preferred)
- Applied knowledge of project management methodology, processes and tools
- Demonstrated ability to work cross-culturally with global colleagues and with TPOs
- Ability to establish and manage relationships
- Previous experience working in cross-functional teams or projects
- Effective and influential communication skills
- Flexibility to adjust to altered priorities
- Proficiency in use of project management tools and techniques (e.g., Critical Chain, ProChain Enterprise)
- Knowledge of regulations and guidelines that apply to the conduct of clinical trials
11
Clinical Trials Management Associate Resume Examples & Samples
- Must meet all requirements for Clinical Project Assistant position and have demonstrated proficiency in all relevant areas
- Under supervision serves as the key operational contact with external investigators and internal stakeholders, for successful implementation of Gilead (GS), Collaborative (CO), Investigator Sponsored Research (ISR) Studies, expanded access programs, and compassionate use programs
- Under supervision may serve as the key operational contact for Gilead (GS) studies, providing assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs
- May take part in fair market evaluations ISRs in collaboration with Clinical Pricing department
- May participate in coordination and input to periodic safety update reports and development safety update reports when requested
- Communicates and collaborates with Medical Affairs, Clinical Research, Regulatory Affairs, CCF, Clinical Supply Management, and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities
- Proactively identifies potential operational challenges and in collaboration with senior team members provides solutions to ensure study execution remains on track
- Supports study drug planning and shipping activities
- Ensures all protocol, budget, contract are appropriately approved, executed, and documented
- Forecasts, tracks and reports CO and ISR milestones and ensures invoice payment
- Provides monthly study updates to the appropriate internal stakeholders
- Maintains internal Clinical Operations databases and document repositories
- Must be familiar with routine medical/scientific terminology
- Must be able to participate in departmental or interdepartmental strategic initiatives under general supervision
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies
- Under supervision may assist in review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports
- May contribute to SOP development
- For GS studies, may monitor or co-monitor study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plan, as required
- May resolve routine monitoring issues
- Responsible for the oversight and management of investigator-sponsored and collaborative studies
- Working knowledge and experience with Word, PowerPoint and Excel
- At least 1+ year of relevant experience and a BS or BA in a relevant scientific discipline or
- At least 1+ year of experience and an RN (2 or 3 year certificate)
12
Clinical Labeling Associate Resume Examples & Samples
- Coordinates approvals for proposed clinical trial label content
- Completion of Forms required for development of label content and execution of clinical labeling activities
- Submits completed Forms to permit execution of the packaging operations at the contract clinical packaging site
- Submits approval of pre-production and executed packaging records
- Communicates bulk drug product delivery target dates
- Participates in project review meetings with contractors
- Monitors on-site clinical packaging activities at the contract clinical packaging facilities as required
- Coordinates and executes of internal toxicology study labeling activities
- Performs review of executed packaging records
- Verification of Form data prepared for the development of label content and execution of clinical labeling activities
- Performs review of pre-production master packaging records
- Coordinates clinical packaging bid reviews
- Develops and maintains departmental SOPs and Work Instructions
- Operates as lead and direct communications with contract clinical packaging site(s)
- Knowledge of cGMP and applicable regulations
- Ability to build productive working relationships and communicate effectively
- Must be action oriented and well organized
- Associates degree in a scientific discipline required along with minimum of 2 years relevant work experience. Bachelor’s degree preferred
- Clinical trial packaging and labeling support experience preferred
- May substitute relevant experience for educational requirement
13
Clinical Reseach Associate Resume Examples & Samples
- Establishing regular lines of communication plus administering protocol and related study training to assigned sites
- Evaluating the quality and integrity of site practices – escalating quality issues as appropriate
- Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
14
Associate Clinical Account Specialist Resume Examples & Samples
- This position requires candidates to be one of the following: a graduate within the last 36 months from an accredited academic program OR accredited EP school OR exiting a branch of the US Military
- Advanced computer skills, and the ability to multitask without the direct oversight of manager required
- Candidates must be willing and able to be located in the Los Angeles, CA Area of the U.S.Selling
15
Associate Clinical Imaging Analyst Resume Examples & Samples
- Requires knowledge of supported server, application, network, security systems, virus protection, and hardware configurations used in conjunction with PACS
- At least 1 year of experience directly supporting PACS
- Possesses analytical and design capabilities
- Demonstrates a customer orientation; establishes and maintains customer relationships
16
Clinical Trials Associate Resume Examples & Samples
- Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory
- Requirements preferred
- Excellent communication, relationship building and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi task
- Proficient in Microsoft Office (e.g., Word, Excel, and Outlook)
- 1-2 years' experience within the Pharmaceutical/CRO industry or equivalent site experience
17
Temporary Clinical Trials Associate Resume Examples & Samples
- B.S in a scientific or allied health field (or equivalent experience)
- 1-4 years of relevant work experience
- Refer to key responsibilities section below
- Exhibits ability to ‘multi-task’ effectively
- Demonstrates a working knowledge of ICH GCP regulations, ICF’s and clinical protocols
- Ability to interact well with various team members and provide value added support to projects
- Displays ability to independently solve routine problems following standard policies/procedures
18
Associate Director, Non-clinical Statistics Resume Examples & Samples
- Deep experience in multivariate methods is required for this position
- Excellent statistical computing skills in packages such as SAS, R, JMP, Minitab and SIMCA-P+
- Coursework/experience should include industrial statistics (DOE, SPC, regression, general linear models, and multivariate methods)
- Effective oral and written communication skills to communicate statistical concepts and analyses to non-statisticians
- Additional experience in Bio/Vaccine Manufacturing and Six Sigma is considered a plus
19
Clinical Trials Associate Resume Examples & Samples
- Assists with preparation of all external and internal documentation, for assigned trials, to ensure such documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocol, under close supervision assists Clinical Project Manager in site management activities which could include review of monitoring report,tracking of site visits, communication with monitors and sites, and other activities as assigned
- Maintains and tracks revisions to all documentation for accuracy, including patient Informed Consent Forms and Case Report Forms
- Assists the Clinical Project Manager in ensuring compliance with Clinical Study Protocol and provides timely updates to assigned Clinical Project Manager to confirm compliance
- Organizes and prepares study files related to study tracking and reporting and submits them to the Trial Master File within established guidelines
- May participate in the training of CRO teams, investigators and staff as needed regarding assigned logistics of the clinical trial
- Tracks delivery and receipt of required supplies and materials to study sites and provides regular status updates
- May mentor more junior Clinical Operations Staff or participate in the on boarding of new personnel
- Demonstrates a working knowledge of ICH GCP regulations and clinical protocols
- Ability to interact well with various team members and provide value added support to project
20
Clinical Reserach Associate, Belgrade Resume Examples & Samples
- University degree in a science related field or a certified health care professional or equivalent certification/licensure from an appropriately accredited institution
- Considerable clinical research monitoring experience with a demonstrated high level of expertise in all aspects of clinical monitoring
- Fluency in English and in the country's native language
- Valid Driver's License where applicable
- In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered
- Expert clinical monitoring skills
- Expert knowledge of FDA guidelines, GCPs and applicable Standard Operating Procedures
- Skills to mentor and train other monitors in a positive and effective manner
- Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology
- Ability to work independently as required
- Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
- Fluency in Italian, both written and spoken
- Good English language and grammar skills
21
Clinical Transplant Associate Resume Examples & Samples
- Referral Management: Manages local regions referral review process for transplant authorizations; collects supporting documentation from available sources & presents case to reviewer per local region procedure. Anticipates leakage out of the Network & develops processes to find & correct it according to local region policy & procedure & NTN exemption process
- Generates & ensures communication of authorizations to the referring provider, COE, member & claims unit. Collaborates w/ the Transplant Coordinator, & local region Utilization Management to ensure that the process fulfills all regulatory requirements. Collaborates w/ the claims department to ensure that claims are paid according to the appropriate contract & fee schedule
- Educates local providers regarding the referral process for Transplant Services; develops & implements systems to ensure that 98% of referrals for Transplant Services occur w/in Centers of Excellence
- Consistently supports compliance of responsibility (Kaiser Permanente code of conduct) by maintaining the privacy & confidentially of information, protecting the assets of the organization, acting w/ ethics & integrity, reporting non compliance, & adhering to applicable, federal, state, & local laws & regulations, accreditation, & licensure requirements (if applicable), & Kaiser Permanente policies & procedures. Performs all other duties as assigned
- Clinical Information Management: Collects COE /Organ specific clinical information for the members w/ approved referrals for transplant; collaborate w/ the Transplant Coordinator to ensure that information is timely & complete
- Collaborates w/ the Transplant Coordinator to ensure accurate & complete Hub Intake Form. Develops & implements systems for ensuring that clinical information from the COE or referring provider is received by the intended recipient in a timely & user friendly manner
- Develops processes & implements monitors for local region in-patient census to identify case managed members that have been admitted to an in-patient facility. Collects clinical information for members approved for transplant; collaborates w/ transplant coordinator & physicians to ensure that information is timely & complete. Performs order entry functions as directed by transplant coordinators & clinicians
- Collaborates w/ transplant coordinators to ensure that accurate information is forwarded to the COE & or retrieved from the COE. Triages requests for clinical information from COE on behalf of transplant coordinators & clinicians
- Access to Clinical Services: Anticipates delay in processes & works to ensure members' timely access to required consultations/diagnostic procedures requested by COE. Coordinates appointments for consultations/diagnostics w/ providers & members according to the medical indication
- Reduces redundancy & outside costs by collaborating w/ the transplant coordinator to maximize repatriation of services whenever it is clinical appropriate & w/in the confines of the members contract w/ the Health Plan
- Ensures that authorization for outside services are accurate & communicated to all effected parties
- Minimum three (3) years of experience in utilization management (required on original description)
- Minimum one (1) year of experience in an ambulatory clinical setting preferred
22
Clinical Trial Operations Associate Resume Examples & Samples
- Interacts with CRO, central laboratory, IVRS systems as needed
- Follows established clinical study standards and procedures to plan and conduct clinical research studies
- Requests, collects and submits site documents
- Tracks study start up status
- Collates and assembles study binders (regulatory, pharmacy, laboratory), study reference manuals and study data collection tools
- Manages and maintains team SharePoint and/or shared drive sites as needed
- Maintains open communication channels with study sites and members of the study team to ensure proper study progress
23
Clinical Imaging Operations Associate Resume Examples & Samples
- Assisting team with quality review of project tracking
- Assisting team with patient data follow up including outstanding data queries and late data inquiries
- Working with internal staff to resolve issues
- Exploring new opportunities to add value to organization and departmental processes
- Helping others to achieve results
- Attending and participating in applicable company-sponsored training
- Ability to work in group setting and independently; ability to adjust to changing priorities
- Knowledge of the drug development/clinical trials process/basic clinical research and/or experience working in a pharmaceutical environment preferred
- Knowledge of “good clinical practices” preferred
24
Associate Clinical Country Lead Resume Examples & Samples
- Maintain current awareness/information pertaining to local clinical knowledge of disease areas researched by Biogen, emerging standards of care, and trial related needs of clinicians in community. Hold specific operational and scientific discussions and act as local GCO expert for the provision of country level therapeutic area, disease area, and program and study information to drive and support global operational strategy. Coordinate cross functional local affiliate input as required to provide appropriate country level input into Clinical Development Plan
- Primary country level GCO/Biogen contact for all GCO clinical studies, leading interactions or managing CCA interactions to ensure timely local information flow and resolution of issues as appropriate with Investigators, affiliate office staff, CRO staff, and GCO/global teams. Understand, analyze and monitor overall Country Performance (KPIs) and support country focused activities to deliver country operational milestones
- Provide and manage investigator and site knowledge/relationships to highlight country level capabilities, interests, needs and satisfaction levels. This would involve the development of a country level GCO investigator engagement strategy, or execution of global strategy (in collaboration with WM or local medical) to position Biogen as the company partner of choice for clinical trials
- Primary country level GCO/Biogen contact accountable for strategic development and execution of country activities related to the required sponsor oversight of CRO and clinical trial activities (e.g. SOV’s, audits, and inspection support)
- Lead and manage required local activities as part of agreed country and site selection process to ensure appropriate input is sought from local treating physicians and other stakeholders. (e.g. investigator assessment of (and feedback on) programs and protocols)
- Support local or regional projects or other CCM activities as a representative of their country(ies)
- Miniumum 5 years relevante experience of managing clinical trial activities, especially sponsor oversight activities in an outsourced model with CROs/vendors
- Deep understanding of cross functional drug development process and high scientific/clinical knowledge across key therapeutic areas enabling CCL to discuss compound, development plans, and protocol endpoints with investigator site personnel
- Ideal candidate will be customer focused, with excellent leadership, interpersonal skills, cultural awareness, high emotional intelligence and collaborative decision making approach. Must build relationships throughout and across the organization whilst operating remotely
- Requires strong organizational skills and leadership skills, especially project management skills, with an ability to set clear goals, align priorities and lead multiple tasks/activitie
- Proven ability to handle a high volume of tasks of varying complexity within a given timeframe and in consideration of relative priorities
- Effective working knowledge of relevant IT tools to promote virtual team working
- Excellent knowledge of clinical operational activities/challenges across local geography
- Strong communication skills, including English language skill in countries where English is not the primary language
25
Associate Chief Clinical Ofcr Resume Examples & Samples
- ACCO Medical partners with the ACCO Surgical and ACCO CVC to work with the Associate Director for Care Management and Capacity Management around bed and capacity management
- Fulfills duties assigned by the CCO, UMHS acts as the CCO in the absence of the CCO UH
- Participation in UH/CVC patient safety huddles
- Provide leadership and on call support for operational, quality, care and capacity issues as a part of the OCA physician on call schedule
- In close collaboration with the Director of Nursing, Medical and the AHD, Medical, guides management of patient flow, including developing systems to facilitate appropriate acceptance, improve intra-hospital transfers, adjudication between services, and manage high occupancy for best patient-care outcomes
- Program & Clinical Management
- Participates with the Director of Nursing, Medical and AHD, Medical in appropriate programmatic improvements and capacity expansions
- Resolves clinical and operational problems of assigned areas consulting with Hospital administrators, nursing leaders, service chiefs and patient care staff utilizing an interest-based problem-solving approach
- In partnership with the Director of Nursing, Medical and the AHD, Medical, actively participates in quality and patient care initiatives and improvements that support organizational priorities, including effectively facilitating the patient care unit medical directors with nurse managers to accomplish designated outcomes in patient care, safety and quality
- Actively participates and leads physician focus on safety, quality, timeliness, financial stewardship and people through
- Progressively responsible experience in the management of health care delivery and a history of successful execution of initiatives
- Excellent oral and written communication and interpersonal skills, as demonstrated by the ability to work effectively with nursing partners, individuals and/or teams, across disciplines
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Associate Chief Clinical Ofcr Resume Examples & Samples
- Works closely with the CCO UH/CVC and other ACCOs to improve the quality of the patient experience in UMHS
- Serves as a key member of the Office of Clinical Affairs leadership team
- Directs and leads multiple complex work streams
- Works collaboratively in a team environment, continually addressing ongoing and new issues, while also exercising appropriate autonomy when needed to meet job requirements
- Works alongside the Director of Nursing, Surgical, the AHD, Surgical and other allied health professions across domains with management, staff and clinicians, requiring the development of rapport and the maintenance of professional relationships. Internal contacts include all levels of management and staff
- Actively participates in training and seminars related to relevant professional and/or leadership development opportunities
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Clinical Subjects Associate Resume Examples & Samples
- Recruit and schedule research participants’ initial and follow-up appointments for supported studies of the MADC/ Michigan Alzheimer’s Disease Core Center, including the University of Michigan Memory and Aging Project, Decision Making for Cardiovascular Therapy in Adults with Mild Cognitive Impairment study; MADC research registry, and the Community Urban Electroencephalogram Study at the University of Michigan Detroit Center in Detroit
- Bachelor’s degree in social science or a health science discipline
- Experience working with older adults with dementia
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CO Clinical Associate Resume Examples & Samples
- Administer medical care to hospitalized patients
- Participate in the performance of minor surgery
- Examines and treats patients in the emergency room
- Oversees the treatment of patients by resident physicians
- Performs laboratory tests and other diagnostics
- Participates in training conferences and makes rounds
- Work requires the analytical skills to collect information from diverse sources, apply professional principles in performing various analyses, and summarize the information and data in order to solve problems OR design relatively complex systems and programs that cross departmental/divisional areas
- Work requires the ability to communicate effectively both orally and in writing and provide empathy in difficult interpersonal situations
- Proofreading and/or reviewing documents
- Using a keyboard to interact with computer systems
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Associate Clinical Site Manager Resume Examples & Samples
- Bachelor's degree in Life Sciences, Allied Health, Nursing or Pharmacy, and 3-5 years of clinically related or relevant experience
- Knowledge of general clinical research including Investigator site issues, important milestones and strategies to ensure timelines are met
- Knowledge of the pharmaceutical industry and the pre-clinical, clinical, regulatory and commercial components
- A detailed understanding of project planning and management methods
- 1604941
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Associate VP, Clinical Resources Resume Examples & Samples
- Provides strategic direction in the development of fee for service physician leadership programs and offerings
- Supports the Performance Management teams’ work in clinical leadership, patient safety, clinical quality and advisory services
- Delivers content in person or remotely to national and geographic networks in physician engagement and education activities
- Serves as the operational lead with strategic input for the TCPI team and program which includes relationship management with CMS. Responsible for team performance in helping participants achieve practice transformation and associated quality and cost performance
- Works with the Vizient innovations team and product development team to create physician targeted solutions that include providing identified content, tools and metrics that will improve clinical care, patient access and patient and provider satisfaction
- Leverages knowledge gained in TCPI to improve Vizient solutions and offerings such as Faculty Practice Solution Center (FPSC) and Access
- Supports the Vizient supply networks in physician engagement on utilization and cost reduction strategies
- Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO); MBA, MHA or MMM preferred
- Medical specialty Board certification required
- Minimum 15 years of clinical and/or administrative experience. Experience should include tenure as a practicing physician, a medical staff leader, and/or senior executive of an organization of significant size and complexity that would prepare the individual for the leadership role
- Demonstrable experience in successfully leading teams that exceed their goals and deliver customer value
- This person must have a successful track record in leadership, working with physicians, management, and the governing body, and a proven ability to implement strategic plans and to proactively “make things happen
- Candidates must be politically savvy and diplomatic leaders who can interact comfortably with senior executives and physician leaders and understand how top executives think and work.The individual must be able to achieve consensus and find common ground for the benefit of all concerned
- Possess executive presence and high emotional intelligence who is affable, diplomatic, approachable, customer service oriented and responsive.The individual should also be well organized and possess effective implementation and prioritization skills
- Should possess excellent business judgement and acumen that includes good financial skills, financial analysis, and budgeting skills. Understands physician compensation models
- A creative individual who is a generator of new ideas and concepts and comfortable working within a matrix organizational structure
- Understands quality improvement and performance improvement methodologies with a passion and a desire to know and share best practices and best performers
- Strong consultative skills and change management skills to influence others, and with excellent presentation and project management skills
- Personal characteristics which include exceptional verbal and communication skills on an individual and group basis, excellent writing skills, professional appearance, and an executive demeanor
- Candidates must possess excellent interpersonal and relationship building skills
- A proven track record as an innovator who can identify trends, formulate and convey concepts, and implement approved action plans.A broad understanding of healthcare industry dynamics, especially reimbursement is very important
- The candidate will be self-confident, decisive, a team player, exhibit high integrity, and demonstrate sensitivity to others.This person must be able to establish lasting relationships
- The candidate must be willing to travel up to 50%.It will be important for this role to visit members, and attend Vizient, Inc. meetings in addition to conferences and forums
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Senior Associate, Clinical Production Resume Examples & Samples
- Manufacture clinical grade cellular therapeutic products to supply CCT Clinical Program
- B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 1-3 years of relevant experience in a clinical laboratory or blood/cell culture processing environment
- Ability to work in an aseptic environment requiring successful completion of qualification program
- A basic knowledge in various computer applications. Ability to work with Microsoft Word and Excel required. Understanding of Microsoft Access or database entry is preferred
- Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for extensive walking, standing and occasional lifting of heavy materials. Frequent visual demands require macroscopic and microscopic observations
- Employees must work in areas where posted Universal Precautions must be observed and practiced. Associates work daily with potentially harmful and/or hazardous agents including asphyxiating gases (nitrogen), potentially carcinogenic and/or inflammable chemical reagents and sharps
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Associate Dean for Clinical Programs Resume Examples & Samples
- Provides oversight and direction of all clinical services offered under the clinical umbrella of the School of Nursing (e.g., faculty practice, clinical research, community programs, FQHC), including but not limited to financial management, strategic planning, quality management, EHR, compliance, value-based care, and program evaluation and control
- Ensures that clinical practitioners appointed and reappointed to clinical services in the School of Nursing are qualified and properly credentialed for the particular roles they perform
- Develops and implements policy and guidelines to serve as the operating framework and vision for clinical services rendered by the SON
- Cultivates strategic approaches to establish or expand key clinical initiatives, i.e., faculty practice, community outreach and programs, clinical research, etc
- Collaborates with SON academic deans and RBHS schools to enhance clinical inter-professional and inter-disciplinary education, research, and practice
- Secures sources of revenue and funding from faculty practice, clinic services, collaborative partnerships, and clinical research through reimbursement for care and extramural grant activity
- Responsible for oversight of clinical contracts and collaborative practice agreements for inter-professional practitioners and affiliations
- Assures that clinical programs and services are in compliance with Federal, State, local government laws, and regulatory agencies, as well as with Medicare, Medicaid, and other third-party payers
- PhD (or equivalent) in nursing (preferred)
- History of scholarship, program/research funding
- Progressive leadership and administrative experience, including fiscal administration, grants management, program planning and evaluation, knowledge of regulatory and insurance requirements for clinical practice
- Superior interpersonal skills and robust ability in addressing a highly regulated and intense healthcare market
- Eligibility for licensure as a RN in the state of New Jersey
- Certification as APRN or equivalent (preferred or extensive experience in practice management)
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Associate Principal, Clinical Improvement Resume Examples & Samples
- Plans and leads quality execution of large, complex projects, programs or operations (e.g., consulting, technology, client support).Consistently oversees a substantial engagement portfolio and manages project P&Ls
- Manages and develops a number of direct reports and/or project team members; coaches others to be high-performers.Has formal people manager responsibilities including performance management,professional development,recruitment, retention, engagement, etc
- Supports function/practice development activities, including development, launch and implementation of new or improved services/products
- Crafts and delivers influential communications with clarity and confidence to senior-level audiences
- Meets or exceeds contractual obligations, including savings guarantees for all assigned projects and leading to high member satisfaction
- Supports sales efforts by supporting proposal generation, identifying client upsell and cross-sell opportunities, finding new sales ventures and serving as a subject matter expert throughout the sales process
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Clinical Trials Associate Resume Examples & Samples
- Assists with preparation of all external and internal documentation, for assigned trials, to ensure such documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocol, under close supervision
- Assists Clinical Project Manager in site management activities which could include review of monitoring report, tracking of site visits, communication with monitors and sites, and other activities as assigned
- B.S. (or equivalent experience) and 1 – 4 years of relevant work experience
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Clinical Trials Associate Resume Examples & Samples
- Assists clinical monitoring team with compliance or maintenance of regulatory standards, Standard Operating Procedures (SOPs), and Work Instructions (WI). Assists Clinical Monitoring staff with site management activities, including serving as a company and sponsor representative for sites on assigned studies; conducting telephone and other communication activities with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines
- Creates and assists with maintenance of project files; handles project correspondence; reviews project files for completeness and accuracy. Creates project-specific forms
- Participates in file audits. Prepares and maintains Study Reference Manual and site reference tools. Arranges for receipt of administrative and regulatory documents
- Coordinates the packaging, shipping, and tracking of study supplies and materials
- Transcribes accurate meeting minutes and action items. Tracks site level information, site visits, monitoring reports, study documentation and clinical supplies, within the deployed Clinical Trial Management System (CTMS), if required
- Assists with coordination of team meetings, attends meetings, and prepares meeting minutes. Assists in preparation for and attends investigator meetings. .Maintains timely and effective communication among team members and site staff. May contact site staff as needed for critical information. Drafts and prepares documents for mass dissemination
- Handle receipt, tracking and disposition of Case Report Forms and Queries
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Clinical Information Management Associate Resume Examples & Samples
- Manage the day to day activities of the physical archive
- Work with existing electronic systems, to archive and research clinical records
- Manage CRO/Partner record migrations
- Work with TMF Compliance and Oversight team to implement and maintain an eTMF ensuring appropriate archiving processes are in place
- Carry out complex searches across various internal and external systems to ensure retrieval of complete and accurate information as it relates to inspection readiness
- Collaborate with Clinical Development Execution functions to maintain a compliant and inspection ready Clinical archive
- Support compliance activities for internal and external inspections and audits
- Independently solve problems of moderate complexity with limited supervision
- Assist in review of procedures to identify gaps and revise accordingly
- Analyze new regulations and guidelines and makes process improvement recommendations to group
- Prepare and deliver effective presentations for department meetings
- Represent TMF Compliance and Oversight on assigned project sub-teams and/or task forces
- Posses general knowledge of records management and archiving principals, procedures, and common best practices
- Displays good interpersonal skills and ability to deal effectively with a variety of personnel
- Posses strong command of Microsoft office suit
- M.S. (or equivalent degree)
- Demonstrates sound knowledge and understanding of applicable GCP regulations and industry best practices
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da Vinci Clinical Territory Associate Resume Examples & Samples
- Work with the Clinical Sales Manager to develop a strategy to drive utilization of the da Vinci®Surgical System
- Become a da Vinci®Surgery expert across all primary surgical specialties in order to support the development of surgical robotics programs in the assigned territory
- Support field efforts to achieve quarterly sales goals
- Support regional sales and marketing development events that create system awareness and procedure adoption
- Responsibly manage administrative tasks; reporting of sales/procedures, outcomes of sales activities, submission of expense reports, etc
- Be a resource to the surgical team, providing guidance and insight on the use of the da Vinci®Surgical System
- Bachelor degree required
- Two years of work experience
- Ambition and strong work ethic
- Ability to excel in a high-energy, fast-paced environment
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da Vinci Clinical Territory Associate Resume Examples & Samples
- Case Support -Be a resource to the surgical team by providing guidance, insight, and training on the use of the da Vinci® Surgical System
- Administrative Duties- Responsibly manage administrative tasks: reporting of sales/procedures, outcomes of sales activities, submission of expense reports, and assigned ISU on-line modules using company required software systems
- Minimum 1 year leadership experience or 1 year sales experience
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Temp-clinical Trial Operations Associate Resume Examples & Samples
- Supports CTM or project manager with study start up and execution
- Serves as back-up or point of contact if CTM is unavailable
- Assists CTM or project manager with requesting, collecting, and reviewing site regulatory documents
- Reviews start-up documents (including contracts) and disseminates to the appropriate functional groups (i.e. legal, regulatory)
- Establishes and maintains study TMF with CTM guidance
- Maintains and is responsible for updating data in CTMS
- Collates materials for CRA training and investigator meetings as necessary
- Creates and updates Power Point presentations for the study team
- Assists with study specific document writing and review – (Protocols, ICFs, Source Docs, etc)
- Accompanies CTM or CRA on site monitoring visits
- Works with other departments to provide and receive required information required for achievement of Clinical Research assignments, goals and objectives
- Problem solving/Troubleshooting abilities and resourcefulness
- Fundamental knowledge of the clinical research process and regulations/guidelines
- Effective communication and interpersonal skills; ability to build relationships internally and externally
- Familiarity with medical terms
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Clinical Trials Associate Resume Examples & Samples
- Bachelor’s degree in nursing, life science or healthcare related field
- Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems or equivalent
- Additional complex software application related to clinical trial research. (i.e. electronic data capture or patient diaries, interactive voice response, etc.)
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Associate Chief Clinical Ofcr Resume Examples & Samples
- Fulfills duties assigned by the CCO, UMHS acts as the CCO in the absence of the CCO UH/CVC
- Participation in CVC patient safety huddles
- In close collaboration with the Director of Nursing CVC and the AHD CVC, guides management of patient flow, including developing systems to facilitate appropriate acceptance, improve intra-hospital transfers, adjudication between services, and manage high occupancy for best patient-care outcomes
- Participates with the Director of Nursing CVC and AHD CVC in appropriate programmatic improvements and capacity expansions
- In partnership with the Director of Nursing CVC and the AHD CVC actively participates in quality and patient care initiatives and improvements that support organizational priorities, including effectively facilitating the patient care unit medical directors with nurse managers to accomplish designated outcomes in patient care, safety and quality
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Clinical Subjects Associate Resume Examples & Samples
- Monitor the MSHOP patient referrals from multiple grant clinic sites, complete program enrollment, follow-up, and completion
- Collect pertinent medical & social history to determine patient eligibility before enrollment
- Make initial call to enroll patient in MSHOP
- Record patient contacts
- Answer questions regarding the MSHOP program and discern when a patient should be transferred to their surgeon’s office for more information
- Monitor patient tracker for non-compliance , contacting them to support and encourage participation
- Maintain excellent relationships with clinical staff including: MDs, nurses, PA/NPs, and allied health professionals
- Build MSHOP kits
- Prepare pedometers for patients before distribution
- Keep offsite clinics stocked with kits
- Build boxes for mailing kits
- Mail kits as needed and track info for billing
- The individual chosen will be responsible for meeting the highest standards of customer service including exhibiting a professional and positive image when interacting with patients, faculty, and staff
- Assures compliance with protocols, adherence to good clinical practice guidelines and all other federal, local, and University guidelines
- Associate’s degree, MA or LPN certification
- Background in a medical field and knowledge of medical terminology
- Outstanding organizational skills with meticulous attention to detail
- Computer skills are essential, must be well versed in Microsoft Word, Excel spreadsheets, etc
- Excellent customer service and communication skills, particularly telephone skills
- Proven ability to work well as part of a team and ability to complete tasks independently
- Strong interpersonal skills, ability to manage multiple tasks, and demonstrate high levels of motivation and follow-through
- Experience with MiChart or another Epic medical record system
- Significant knowledge of UMHS policies, procedures, and clinical operations
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Clinical Subjects Associate Resume Examples & Samples
- Attend and recruit research participants from Health Fairs and community outreach events in Ann Arbor and surrounding areas including Detroit
- Conduct research related blood draws/saliva collection in Ann Arbor and Detroit which will include, but not limited to processing, quality control, labeling, storing, handling and shipping of specimens to repositories
- Maintain research appointments calendar
- Coordinate research participant room reservations at the MADC and the U-M Detroit Center in Detroit
- Make appointment reminder calls to research participants; cancel and reschedule appointments as needed
- Administer paper/pencil and computerized neuropsychological examinations to research participants
- Write behavioral observations and score neuropsychological evaluations
- Enter electronic data into secure electronic data capture system database (REDCap)
- Administer 64 channel Electroencephalogram to research participants; upload data into a secure file
- Schedule and place MRI appointments and blood lab orders in electronic health records (MiChart)
- Schedule research participants’ blood collection; coordinate schedule with MCRU technician for blood draws
- Fill out Research Volunteer Forms for the MADC research registry
- Monitor the Best Practice Advisories (BPA) to screen for study eligibility and contact/recruit for MADC supported studies; create Medical Record Number (MRN), and upload data into MiChart
- Generate and ensure appointment letters and initial visit welcome packets are mailed to participants on time
- Assist the Research Administrator in managing regulatory/compliance documents between Wayne State University and U-M Institutional Review Boards as needed
- Ensure all study related documentation is completed accurately
- Work collaboratively with MADC and Neurology clinical trials teams
- Perform general office and administrative duties as assigned
- Available to travel to Detroit; valid driver’s license
- Have basic biospecimen processing skills
- Experience with venipuncture in older adults
- Ability to work some evenings and weekends
- Experience administering neuropsychological examinations
- Experience with electronic data entry into REDCap
- Experience administering 64 channel Electroencephalogram and Brain Vision ActiChamp amplifier
- Computer proficiency (i.e. Microsoft Word, Excel, Power Point and EndNote)
- Confident and highly motivated with excellent multi-tasking ability and record-keeping skills
- Professional demeanor and excellent interpersonal and communication skills
- Ability to work with diverse teams of people in a diplomatic, collaborative and effective manner
- Ability to problem-solve and establish timelines and priorities
- Ability to multi-task and sustain a high level of organization while working with several research studies
- Reasonable knowledge of university policies and procedures
- Research experience with investigator-initiated and federal sponsored trials
- Experience working and interacting with research participants
- Experience monitoring Best Practice Advisories (BPA), creating Medical Record Number (MRN), and uploading research data into electronic health records (MiChart)
- Familiarity using the secure file transfer system MiShare
- Experience administering oral and computerized neuropsychological examinations CogState, NIH Toolbox, National Alzheimer’s Coordinating Center version 3 and FTLD batteries
- Experience administering the Brain Vision ActiChamp amplifier
- Proficiency in using statistical analysis packages such as SAS and SPSS or other research laboratory programs
- Demonstrated understanding of Good Clinical Practice and HIPAA
- A working knowledge of medical terminology and assessment of laboratory values
- PEERRS certified
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Clinical Subjects Associate Resume Examples & Samples
- Screen, recruit, consent and enroll participants for pediatric emergency medicine research studies
- Bachelors degree, or equivalent combination of skills and experience
- Bachelors degree or higher, or equivalent combination of education and experience in a health science discipline, such as biochemistry, anatomy, pathology, nursing, Medical technology, public health, research administration or equivalent
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Clinical Trials Associate Resume Examples & Samples
- Bachelor´s degree in biological sciences or equivalent work experience
- A minimum of 4-5 years of Clinical Trial support experience for diagnostic, medical device or pharmaceutical products
- A solid understanding of project management and familiarity with project management tools
- Experience in CRO/vendor management and contracting
- Knowledge of oncology clinical trials is preferred
- Experience working in parallel projects teams
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Associate Director, Non-clinical Statistics Resume Examples & Samples
- Assumes the leadership role in providing statistical expertise and participates in developing strategies align with regulatory expectations and business needs
- Assist in managing allocation of resources and setting of priorities to effectively meet priorities and objectives; tracks departmental completion of assignments
- Assists in definition of roles and responsibilities, fosters effective team skills, and insures robust results are produced
- Provides guidance and direction to other statisticians in resolving problems, handling data, and determining techniques to use for incoming projects
- Acts as a subject matter expert in authoring / reviewing policies and directives related to Statistics
- Builds and fosters relationships with customers, stakeholders, and support groups globally to understand their statistical analysis needs and determines sound statistical techniques for use
- Collaborates with process analytical teams and subject matter experts in Manufacturing and Manufacturing Sciences & Technology to design studies and analyze complex datasets for process robustness and improvement
- Supports analytical teams in QC and Analytical Sciences & Technology for analytical robustness and continued analytical verification
- Develops and selects appropriate statistical methods for the design and analysis of studies and programs in order to assure batch compliance and prevent rejections, reworks, complaints, and product recalls on a worldwide basis
- Conducts thorough and careful analysis of data, gathers critical information, and provides appropriate recommendations and solutions based on corresponding statistical analyses and business needs
- Represents Global Statistics at management and regulatory agency meetings, when necessary. Prepares responses on statistical issues raised by regulatory agencies pertaining to BMS submissions and inspections
- Furthers the statistical awareness and increases the competency of statisticians and other BMS personnel; participates in their training and development, as required
- Contributes to the globalization, improvement and standardization of processes, procedures and systems in relation to Statistics while maintaining flexibility where required
- Participates in efforts to influence industry practices on statistical and operational issues
- Creates, communicates, and supports the highest commitment to quality and compliance
- Supports the BMS BioPharma Behaviors
- A minimum of 7 years experience in pharmaceutical industry with technical knowledge in the following areas: specifications, stability and statistics
- Ability to work with a wide range of technically and culturally diverse individuals
- Extensive knowledge of FDA / EMEA, CGMPs, Quality Assurance principles, and knowledge of other global regulatory compliance guidelines (e.g. ICH) for drug manufacturing, packaging and distribution
- Able to work independently or as a team member to meet goals, objectives and commitments
- Extensive experience of working directly with manufacturing and marketing leaders, technical experts, Quality, R&D, and Regulatory personnel at domestic and international sites
- Ability to integrate statistical and quality control concepts
- Background in the sciences and understanding of pharmaceutical methods, processes, products, and operations to facilitate an understanding of the problems at hand
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Clinical Subjects Associate Resume Examples & Samples
- Demonstrated ability to work autonomously in study management of clinical subjects
- Demonstrated ability to communicate clearly and effectively, both orally and in writing
- Ability to work collaboratively with other disciplines in the management of clinical subjects
- Good working knowledge and previous experience with standard computer programs, such as: Microsoft Word, Microsoft Excel, and Microsoft Access
- Functioning automobile with insurance for home visits
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Clinical Subjects Associate Resume Examples & Samples
- Knowledgeable in medical terminology and clinical trial processes
- Advanced knowledge with Excel, PowerPoint, Electronic Medical Record systems and/or statistical software
- Experience interacting with physicians and medical staff
- Significant experience in interpreting patient records and collating information for case report forms and databases
- Willing to become certified with the Society of Clinical Research Associate (SoCRA) or the Associate of Clinical Research Professionals (ACRP)
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Temp-clinical Trial Operations Associate Resume Examples & Samples
- Acts as a second point of contact between team members, vendors and study sites to assist with study conduct
- Reviews study start up documents and disseminates to the appropriate functional groups (i.e. legal, regulatory)
- Accompanies the CTM or CRA on site monitoring visits
- Analyzes issues and uses judgment to make decisions
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Clinical Subjects Associate Resume Examples & Samples
- Bachelors degree,or equivalent combination of skills and experience
- A strong interest in medicine and/or human subjects research
- Working knowledge of Microsoft Word, Excel and PowerPoint is highly desirable
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Clinical Trial Management Associate Resume Examples & Samples
- Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based),
- Knowledge of concepts of clinical research and drug development, and
- General therapeutic area education and training
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Clinical Trials Associate Resume Examples & Samples
- Bachelor's Degree or its International Equivalent - Education, Health, Behavioral, Life or Social Sciences, International Development, Human Development or Related Field.Preferred Education and/or Experience
- Master’s degree or its international equivalent preferred
- Related prior work experience in clinical trials required
