Research Assoc Resume Samples

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P Klocko

Princess

Klocko

3038 Giles Common

Detroit

+1 (555) 140 8007

3038 Giles Common

Detroit

Phone

p +1 (555) 140 8007

Experience Experience

Chicago, IL

Research Assoc

Chicago, IL

Corwin-Will

Chicago, IL

Research Assoc

Propose, design, and lead process improvements using cross-functional and industry network to drive improvements to Lilly QC practices
7) Perform equipment maintenance and calibrations and ensure working area is maintained in a 5S state
Assist in composing/developing applications for grants/contracts for funding of research projects
2) Work independently or with other Technical Services personnel to execute experiments
7) Develop new or improved techniques and procedures around specific tasks with minimal supervision
9) Work independently or with other PDTS personnel to execute experiments
Assists faculty in the conduct of research of significant value in the basic and/or translational science area

Dallas, TX

Clinical Research Assoc

Dallas, TX

Pfeffer Inc

Dallas, TX

Clinical Research Assoc

Supplying sites with study binders and assisting study team in developing source worksheets
Manage assigned study sites and networks conducting phase I-IV protocols according to the monitoring plan including source document verification
Assists with review and completion of study standard operating procedures and work instructions
Works closely with management to review and get approval of clinical trial agreements and site specific budgets
Manage data query resolution process with sites and track status updates (i.e. IWS)
Assists in ordering, distributing and receiving investigational product
Participate in all clinical study project meetings from inception to close out, providing advice on contract process, status and timelines

present

Detroit, MI

Research Assoc, Data Mgmt

Detroit, MI

Dickens-Simonis

present

Detroit, MI

Research Assoc, Data Mgmt

present

Assist in the development of protocol and criteria
Works collaboratively with research staff in verifying collected data
Develop and/or modify techniques and protocols related to the research design
Leads database design and oversees database management
Conducts data analysis at predetermined study checkpoints and evaluates study progress and results
Formulates research methods and suggests options for improving quality
Proficient in SPSS, SAS or STATA

Education Education

Bachelor’s Degree in Public Health

Boston University

Bachelor’s Degree in Public Health

Skills Skills

3) Research lab experience may include research in GMP/QSR environment, cross-functional teamwork, and independent experimentation in method development and validation
7) Able to work in cold environment; able to lift, push, or pull up to 50 pounds
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
7) Good interpersonal skills, good verbal and written communication skills
7) Able to work in cold environment; able to lift, push, or pull up to 35 pounds
4) Ability to handle multiple tasks concurrently while paying attention to details
10) Able to work in cold environment; able to lift, push, or pull up to 35 pounds
Excellent working knowledge of cGMP regulations
Excellent teamwork and communication skills
Attentive to detail

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Research Assoc Resume Examples & Samples

3) Contribute to technical feasibility analysis of complex research and design concepts
4) Evaluate results relative to product requirements, definitions and/or program goals
5) Play a lead role in the evaluation, selection and adaptation of various techniques, which accomplish business objectives such as quality and cycle-time
6) May provide training and supervision to junior members within the discipline. Routinely provide advice and assistance to team members regarding unique problems
7) Devise new approaches to complex problems through adaptations and modifications of standard technical principles. Incorporate new methods and technologies for improving existing or new products/processes
8) Maintain current knowledge of relevant QSRs and other regulatory requirements related to R&D (product development, design and safety) to ensure compliance in all research, data collection and reporting activities
9) Develop budgets and activity schedules of limited scope. In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations
10) Independently plan and execute a series of design and/or technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines
1) The position requires relevant laboratory skills, writing skills, and computer skills plus teamwork/interpersonal skills
2) Bachelor's degree in a scientific discipline with at least 5-7 years or MS with at least 3-5 years relevant experience, or equivalent
3) Research lab experience may include research in GMP/QSR environment, cross-functional teamwork, and independent experimentation in method development and validation

Research Assoc Resume Examples & Samples

Bachelor's degree in a scientific discipline
Research lab and/or manufacturing experience in GMP/QSR environment is useful, ideally in the biologics industry
The position requires relevant laboratory skills, writing skills, and computer skills plus teamwork/interpersonal skills

Research Assoc Resume Examples & Samples

1) Design appropriate experiments to achieve process improvements with minimal supervision
2) Work independently or with other Technical Services personnel to execute experiments
3) Supervise and develop a scientific staff of at least one full time employee and several temporary employees
4) Plan and conduct bench scale and pilot scale experiments
5) Assessment of new technology and application to our existing processes
6) Utilize robust statistical analysis to draw appropriate conclusions from the data
7) Develop new or improved techniques and procedures around specific tasks with minimal supervision
8) Write SOPs and batch records, and develop research outlines for scientific projects
1) Knowledge of protein purification techniques
2) Experience in protein process development
3) Knowledge of analytical tools for analysis of proteins
4) Experience with DOE (design of experiments), six sigma, and lean manufacturing a plus
5) Knowledge of GMPs
6) Good interpersonal skills, good verbal and written communication skills
7) Able to work in cold environment; able to lift, push, or pull up to 50 pounds
MS degree and > 4 years related experience
PhD and 1 year related experience

Research Assoc Resume Examples & Samples

Set up tracking tools, assist in develop forms and document procedures
Summarizes data for progress reports
Responsible for reviewing own work to ensure data quality
Bachelor's degree in the healthcare field

Research Assoc Resume Examples & Samples

1) Conduct laboratory bench and pilot scale protein purification studies, including sample collection, sample preparation, and sample submission
2) Use sophisticated laboratory instrumentation and computer systems to collect and record data
3) Perform advanced assays requiring precise analytical skills and an understanding of biological and chemical principles
4) Complete all testing and analyses of experimental materials in a timely and appropriate manner
5) Prepare study protocols/final reports, maintain data integrity and ensure compliance with company SOPs, GLP, and cGMP regulations
6) Prepare buffers and solutions
7) Perform equipment maintenance and calibrations and ensure working area is maintained in a 5S state
8) Ensure personal training requirements are met
9) Work independently or with other PDTS personnel to execute experiments
1) Knowledge of protein separation and purification techniques
2) Understanding of plasma fractionation is preferred
4) Ability to handle multiple tasks concurrently while paying attention to details
5) Experience with DOE (design of experiments), six sigma, and lean manufacturing a plus
6) Knowledge of GMPs is a plus
7) Good interpersonal skills, good verbal and written communication skills
8) Solid organizational skills
9) Ability to work independently, and follow specific instruction to accomplish the tasks
10) Able to work in cold environment; able to lift, push, or pull up to 35 pounds
Bachelors Degree in a scientific discipline with at least 2-3 years relevant experience, or Masters Degree

Research Assoc Resume Examples & Samples

Analysis of test articles by appropriate biochemical methods such as: HPLC, UV-Vis, and compendial test methods including pH, osmolality, physical appearance, and particle size analysis
Initiating QC responsibilities such as sample coordination, lab equipment maintenance, QC document management, QC inventory control and reconciliation of sample requests/documents as needed
Monitoring laboratory equipment for temperature and conformance to specifications and applying acceptable cGMP practices during execution of all work tasks
Exhibit strong teamwork skills by sharing knowledge and troubleshooting assistance with coworkers, technical mentoring of less experienced associates
Delivery of independent projects by
Propose, design, and lead process improvements using cross-functional and industry network to drive improvements to Lilly QC practices
Development of new methods for validation and transfer, including assay data review
Compiling and analyzing data for documentation of test procedures and preparation of reports/graphs to present to manufacturing leadership
Perform document reviews and author new QC lab standard operating procedures (SOPs)
BS in a related science (e.g., Chemistry, Biochemistry) with minimum 8 years (e.g. regulated compliance industry, FDA industry), or Masters in related science (e.g. Chemistry, Biochemistry) with minimum 6 years of experience (e.g.regulated compliance industry, FDA industry)
Previous HPLC experience (method transfer, method validation, method development)
Attentive to detail
Good computer skills
Ability to work independently and achieve problem resolution with minimal supervision

Clinical Research Assoc Resume Examples & Samples

Ensure the site Investigator Folder is up to date and mirrors the Novartis TMF. Responsible for collecting regulatory documents from site and filing in the Novartis TMF. Prepare and collect study site documents
Responsible for utilizing and updating electronic systems to perform job functions (e.g. Outlook, WinFx, ClinTransfer, IMPACT, IWS, eTMF, webEDI, I.MAN, STARS, Vantage, SSU Database, Investigator Portal, LMS, ESOPs, iLearn, Expense reimbursement, CWT Horizon, Metrixx, Timecard, PMP, multiple eCRF applications). Serve as a reference to other CRAs on electronic systems. May be responsible for assisting with the evaluation, design and implementation of new systems
Perform additional roles and functions for GenMed Clinical Operations as assigned such as a trial Lead CRA, systems superuser, or committee member
Support the successful implementation of innovative processes and technologies.#LI-TW1
Solid medical and business knowledge
Three to five years of experience as a CRA. Trial Lead CRA experience desirable
Demonstrated ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to management or clinical team
Advanced understanding of clinical development, knowledge and experience in international (FDA, EMEA, ICH) and local regulations

Research Assoc Resume Examples & Samples

Highly organized and self-motivated individual with solid understanding of biopharmaceutical purification process development. Strong multidiscipline problem solving skills, excellent communication skills, attention to detail, and ability to lead and influence cross-functional peers and/or upper management. The individual must also have
Hands-on experience of purification process development including chromatography, filtration and analytical assays to monitor processes and product characteristics
Knowledge of cGMP manufacturing and familiarity with engineering concepts; Knowledge of cell culture principle and techniques
Ability to establish and maintain accurate documentation under appropriate guidelines; Ability to present to peers and management team with a concise and fact-based approach
Able to communicate well with other groups, and to provide timely feedback to manufacturing group for continuous improvement
Team oriented, shares information and coordinates tasks effectively with others
Ability to thrive in a fast-paced environment and to multi-task, with good organizational and time-management skills
Must have passion to innovate and drive for solutions, and eagerness to learn and continuously improve

Research Assoc Resume Examples & Samples

1) Plan and conduct laboratory bench and pilot scale protein purification studies, including sample collection, sample preparation, and sample submission
10) Assessment of new technology and application to our existing processes
11) Utilize robust statistical analysis to draw appropriate conclusions from the data
12) Write SOPs and batch records, and develop research outlines for scientific projects

Research Assoc, Data Mgmt Resume Examples & Samples

Leads database design and oversees database management
Develop and/or modify techniques and protocols related to the research design
Conducts data analysis at predetermined study checkpoints and evaluates study progress and results
Formulates research methods and suggests options for improving quality
Assist in the development of protocol and criteria
Works collaboratively with research staff in verifying collected data
Proficient in SPSS, SAS or STATA
Preferably has at least 3 years of experience

Postdoctoral Research Assoc Resume Examples & Samples

Strong skills with Python, including OOP and multi-tasking
Familiarity with autonomous vehicles or robots
Familiarity with GPU based environment/programming
Experience with CUDA, NVIDIA Jetson TX1
Hands on experiences with Kalman, Extended Kalman filters, Cascades
Hands on experiences with optimization theories and real-world problems

Clinical Research Assoc Resume Examples & Samples

Responsible for establishing and maintaining Electronic Trial Master filing systems, securing essential documents and monitoring files and databases for accuracy and completeness
Responsible to perform clerical functions, maintain office / study supplies and equipment, and scanning and electronic filing
Responsible for establishing accounts in billing systems within compliance guidelines and issuing payments to vendors and investigators according to executed agreements
Works closely with management to review and get approval of clinical trial agreements and site specific budgets
Tracks study status, enrollment, regulatory documentation and site start up status
Assists in ordering, distributing and receiving investigational product
Assists in user acceptance testing and evaluating new upgrades
Assists with the preparation of technical reports, summaries, templates and protocols
Supplying sites with study binders and assisting study team in developing source worksheets
Distributes updates to study sites
Records, compiles and distributes minutes from team meetings
Maintains all pertinent study correspondences between the sponsor, study sites and third parties
Assists with review and completion of study standard operating procedures and work instructions
Coordinate research Investigator, Coordinator and monthly forum meetings and newsletters

Clinical Research Assoc Resume Examples & Samples

Serves as Clinical Research Coordinator/Assistant on multiple protocols, with multiple PIs depending on complexity study and condition of study patient population not to exceed the number determined safe to conduct as directed by supervisor. Research specific to Pulmonary, Cardiac, and ICU which may involve both in-patient (ICU) and out-patient research. Coordinates daily operations of clinical (human) research studies in Internal Medicine, Pulmonary Critical Care Division, with a major focus on pulmonary related diseases
Prepares/submits IRB required documents, including but not limited to, Initial Review, Study Protocol, Informed Consent Forms, Questionnaires, Study Recruitment/advertising material, Investigator Brochure, IND safety reporting, Continuing Reviews, Adverse Events (AE) and Serious Adverse Events (SAE)and other IRB documentation
Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places on Informed Consent Form (ICF) & HIPAA form. Assures that amended consent forms are appropriately implemented and signed
Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials. Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.)
Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document/form, case report forms (CRFs), enrollment/screening logs, and drug/device accountability logs
Reviews and comprehends the research protocol. Screen potential study patients - evaluate protocol defined inclusion and exclusion criteria. Explain research and medical procedures to study patients (and family if needed) in Spanish if necessary. Answer patient questions, re-iterated MD instructions and interpret if necessary
Schedule research related patient visits. Assists physician with scheduling of necessary procedures and escorts subjects to procedures in the hospital. Schedules, prepares for, and staffs routine visits from CRAs monitoring research procedures
Collects data as required by the protocol. Records research data. Collects necessary information from patient charts (i.e., medications, laboratory, ECG and x-ray reports, and charge sheets) and records data in source documentation
Process routine clinical samples (i.e. blood, urine) and label specimens appropriately and assure prompt shipping if to outside laboratory. Submit request for dry ice and ship and label samples. Process routine clinical samples (i.e. blood, urine) and label specimens appropriately and assure prompt shipping if to outside laboratory. Submit request for dry ice and ship and label samples
Associate’s degree in a field of study related to the clinical research trial plus one (1) year related experience or a combination of related education and/or experience to equal three (3) years
Certified Clinical Research Professional as defined by The Society of Clinical Research Associates or ability to obtain certification as a Clinical Research Professional within two years from date of hire or upon eligibility
Bilingual - Spanish/English
Excellent organizational skills to independently manage workflow
Ability to prioritize quickly and appropriately
Familiarity with Microsoft Office Suite
Pulmonary and/or critical care or work as a respiratory therapist, clinical research/human subjects research experience involving research of medications in the process of being approved by the FDA by pharmaceutical companies (not animal, basic, or epidemiologic research)
Knowledge of good clinical practice, FDA , OHRP, HIPPA, policies. IATA training in shipping biologic specimens

Clinical Research Assoc Resume Examples & Samples

Position will review and assist in the negotiation of terms and conditions while adhering to all applicable Baxter policies
Participate in all clinical study project meetings from inception to close out, providing advice on contract process, status and timelines
Partner with Legal, Clinical Project Manager and other functional groups to resolve issues in a timely manner and provide guidance on complex contract situations
Manage the Clinical Research Organization (CRO) with respect to contracts
Continually seek and suggest innovative and more efficient ways to carry out duties
Provide mentorship and training to other Contract Associates as needed
Demonstrate and incorporate Baxter competencies in executing responsibilities
Ability to maintain effectiveness under changing circumstances and priorities
Excellent verbal and written communication, presentation, interpersonal and organizational skills required
This position requires a sound knowledge of various computer software and meticulous attention to detail

Research Assoc Resume Examples & Samples

Assists faculty in the conduct of research of significant value in the basic and/or translational science area
Plans, conducts, and manages research projects within the federal and institutional regulations and policies
Collaborates with researchers, external agencies and institutions to develop cooperative research initiatives
Trains technical staff, students, fellows & physicians in lab procedures
Reviews manuscripts for peer-reviewed journals
Assist in composing/developing applications for grants/contracts for funding of research projects
Promotes free discussion, research progress, and overall morale
Responsible for appropriate use of research funds
May supervises staff and students
Master’s degree, 5-7 years of scientifically relevant experience required
Bachelor’s degree 10+ years of scientifically relevant experience required

Research Assoc Resume Examples & Samples

Plans, conducts research projects within the federal and institutional regulations and policies
Trains technical staff, students in lab procedures
Assists with the submission of grant applications/contracts and funding of research projects
Participates in free discussion, research progress, and overall morale
May supervise students
Terminal degree (MD, PhD, DVM), 1or more years Post-Doctoral fellowship experience
Master’s degree, 3-5 years of scientifically relevant experience required
Bachelor’s degree, 7+ years of scientifically relevant experience required

Clinical Research Assoc Resume Examples & Samples

Position will review and play a key role in negotiation of terms and conditions while adhering to all applicable Baxter policies
Manage Clinical Research Organizations (CROs) with respect to contracts
BS/BA required and/or minimum 4 years of experience
Paralegal and/or legal analyst experience
Extensive experience negotiating contract terms and conditions

mAb Research Assoc Resume Examples & Samples

Broad knowledge and experience in cutting-edge research areas, familiar with various antibody generation technologies
Knowledgeable of antibody cloning
Well-organized, detail-orientated, and self-motivated
Master with minimum of 3 years of monoclonal antibody experiences or equivalent educational degree and experience is required
Highly experienced in monoclonal antibody generation, and strong problem-solving skills in all aspects of mAb generation process. Experience in developing antibody pairs for diagnostic/detection kits is highly desired
Hands-on experiences of multiple antibody characterization techniques including but not limited to ELISA, Western blotting, IP, IF and Biacore (SPR)

Clinical Research Assoc Resume Examples & Samples

Responsible for coordinating research activities as defined in research study protocols and PI
Responsible for screening potential study patients evaluate protocol defined inclusion and exclusion criteria
Responsible for ensuring 100% documentation of ICF/HIPAA and maintain in study binder/files
Having two years of experience as a full-time Clinical Research Professional (or 3500 hours part time) during the last five years
Experience working with Clinical Trials

QC Research Assoc Resume Examples & Samples

Bachelor or above degree or above in Biology, Chemistry or related field
5+ years experience as a QC specialist with strong sense of quality in mind
Master of the QC skill of WB, ELISA and Bio-Plex

Clinical Research Assoc Resume Examples & Samples

Two (2) years of direct experience in clinical biomedical and/or behavioral research required
(LC: RN-TN) Must possess a current Tennessee State Board of Nursing license if primary residence is Tennessee or a Nurse Licensure Non-Compact state
(LC: RN-MISS or RN-AR) Must possess a current State Board of Nursing license in the state of primary residence if the state is a Nurse Licensure Compact state

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