Clinical Trial Associate Resume Samples
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Clinical Trial Associate Resume Samples
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SH
S Harvey
Salvatore
Harvey
26481 Leonor Pass
Boston
MA
+1 (555) 693 7692
26481 Leonor Pass
Boston
MA
Phone
p
+1 (555) 693 7692
Experience
Experience
Chicago, IL
Clinical Trial Associate
Chicago, IL
Cummerata and Sons
Chicago, IL
Clinical Trial Associate
- Ensure work is performed in accordance with industry standards, federal and state regulations, accreditation standards and Berg Pharma mission and core values
- Supports and/or tracks external access rights to Clinical Trial Management Systems
- Assist with documents during study start-up including CDAs and CTAs
- Assist with compilation of regulatory documents
- Perform essential support for clinical research throughout all stages of a project
- Assist the CS in organizing investigator/site initiation meetings and/or first dose/monitoring visits
- Performs data entry into the CTMS system for study or client information
Houston, TX
Clinical Trial Associate, Outsourcing
Houston, TX
Zieme LLC
Houston, TX
Clinical Trial Associate, Outsourcing
- Work cross functionally on reporting enhancements and process improvements
- Works collaboratively with clinical team on month end reconciliation
- Financial contract review support and in gathering month end financial reporting from CROs/Vendors
- Supports ClinOut& Fin Sr. CTA, Director, and Clinical Ops CTMs in month end clinical project accrual reporting and reforecasting efforts in support of the clinical projects
- Supports ClinOut& Fin Sr. CTA with collection of financial documentation supporting contract milestones, Sarbanes-Oxley compliance, accruals and monthly financial reconciliation
- Provide operational input on development, management and maintenance of study plans and tools
- Defines TMF issues and works with manager to resolve problems
present
Detroit, MI
Senior Clinical Trial Associate
Detroit, MI
Rolfson Group
present
Detroit, MI
Senior Clinical Trial Associate
present
- Participate in process improvement and development: SOP development, training, process mapping, and other departmental activities
- Use performance metrics and quality indicators to assist the clinical trial manager in driving study execution
- Participate in inter-departmental workgroups to create or enhance processes
- Participate in vendor specification development and management/oversight
- Develop and maintain a good working knowledge of relevant protocols
- Contribute to general departmental administration and the development and continuous improvement of departmental procedures
- Take on career developmental activities/tasks as necessary
Education
Education
Bachelor’s Degree in Clinical
Bachelor’s Degree in Clinical
Michigan State University
Bachelor’s Degree in Clinical
Skills
Skills
- Attention to detail, solid execution, strong interpersonal skills, and a team player
- Computer Literature: Good Knowledge at user level of Microsoft Office. Proficiency in Microsoft applications
- Comfortable with technolgy and ability to learn new systems quickly
- Excellent organisational skills and good attention to detail
- Good interpersonal skills, ability to successfully interact with a wide range of people
- Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint
- Strong attention to detail
- Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments
- Solid knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
- Strong knowledge of MS Word, Excel, PowerPoint and Outlook
15 Clinical Trial Associate resume templates
Read our complete resume writing guides
1
Senior Clinical Trial Associate Resume Examples & Samples
- 35% - Study Start Up
- Facilitate CDA & Contract Execution Process (Routing and
- Manage related task specific study vendor
- Create &/or present study or task related information to CRO/Investigators
- Under supervision of study manager or clinical lead, may assist with tasks typically associated with study management such as site visits, clinical document/ report review, ICD
- Take on mentor role for existing & new CTA team members
- Take on career developmental activities/tasks as necessary
- Associates/Bachelor's degree and/or equivalent relative experience required
- Minimum 2-4 year's experience in supporting or managing tasks within clinical trials
- Relevant experience in clinical research or related field
- General knowledge of regulatory requirements and guidelines governing clinical research
- Comfortable with technolgy and ability to learn new systems quickly
- Strong knowledge of MS Word, Excel, PowerPoint and Outlook
- Must be able to work in a fast paced environment with demonstrated ability to juggle
- Ability to present clinal information in a professional forum
2
Clinical Trial Associate Resume Examples & Samples
- 20% - Study Maintenance
- Support SUSAR distribution
- Facilitate contract execution & study related PO creation for any change orders
- 15% - Study Close Out
- Assist study team with preparation for audits/inspections
- 25% Departmental Tasks
- Maintain knowledge and act as team super user for related systems (e.g. CTMS, R&D Select, PO creation, Sharepoint)
- Maintain up to date training record attending internal/external training as necessary
- Participate in inter-departmental workgroups to create or enhance processes
- Associates/Bachelor's degree or relevant equivalent experience preferred
- Minimum 0-2 year's experience in relevant field (eg. Clinical Site, CRO, Sponsor or Clincal trial Vendor)
- Adequate Good Clinical Practice training
- Must be able to professionally interact and communicate with visitors, vendors and individuals at all levels of the organization
- Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands
- Ability to work successfully within a cross-functional team
- Understanding how their input and role coordinate more effective business practices for Shire’s Clinical Program’s business overall and committing to the culture, vision and mission of Shire
3
Senior Clinical Trial Associate Resume Examples & Samples
- 35%: Study Start Up
- 15%: Study Maintenance
- 25%: Departmental Tasks
4
Senior Clinical Trial Associate Resume Examples & Samples
- Facilitate CDA & Contract Execution Process (Routing and tracking of study specific contracts)
- Manage study specific PO Creation
- Collaborate with Study Manager and CRO to ensure accurate study specific CTMS setup and data feeds
- Liaise with Transparency group to ensure Clintrials.gov is updated accordingly
- Participate in creation and distribution of sponsor specific study aides/materials and communications
- Key point person for R&D select background checks
- Collate documents required for the EC/IRB/HA submissions
- 15% - Study Maintenance
- Assist Clinical Study Manager in tracking study related activities which are not appropriate to be outsourced
- Agenda distribution & minute taking for internal study team meetings
- Maintain internal & external contacts lists in CTMS
- 10% - Study Close Out
- Assist study team in close out in CTMS
- Liaise with Transparency group to ensure Clintrials.gov and results are updated/distributed accordingly
- 15% - Study Management Tasks (as necessary)
- Under supervision of study manager or clinical lead, may assist with tasks typically associated with study management such as site visits, clinical document/ report review, ICD template generation and/or review, review IMP release packet prior to initiation, etc
5
Clinical Trial Associate Resume Examples & Samples
- Bachelor's Degree in a Life Science
- 1-5 years relevant industry experience in quality, regulatory, compliance, clinical research, or drug development
- Knowledge of global clinical trial transparency and data sharing requirements
- Experience with data entry into clinical trial public websites
6
Senior Clinical Trial Associate Resume Examples & Samples
- 35%:Study Start Up
- 10%:Study Close Out
- 25%:Departmental Tasks
- Maintain knowledge and act as team super user for related systems (e.g. CTMS, R&D Select, PO creation, SharePoint)
7
Clinical Trial Associate Resume Examples & Samples
- 40%: Study Start Up
- 20%: Study Maintenance
- 15%: Study Close Out
8
Clinical Trial Associate Resume Examples & Samples
- Strong oral and written skills with proficiency in English
- Analytical approach and anticipation of problems
- Ability to multi-task effectively and prioritize assignments from multiple sources
- Basic knowledge of clinical research budgets including processing and tracking of site and vendor payments
- Strong knowledge of MS applications including (but not limited to) MS Project, Word, Excel, PowerPoint
- Provide operational input on development, management and maintenance of study plans and tools
- Monitoring visit report review
- Informed Consent review
- Support Health Authority inspections and CQA audits
- Ensure full compliance (of the required data in study management tools)
- Collaborate with vendors and other internal stakeholders regarding study specific issues and follow through to resolution
- Manage Trial Master File set-up, ongoing quality review, and final reconciliation
- Reconcile IP at study level in collaboration with IMSC
- Actively contribute to study meetings including presentation subject matter expert, generate, finalize and distribute study team agendas and meeting minutes
- Contribute to development / coordination of study training for study team, investigational sites, and vendors
- Manage vendor and site payment processing and tracking
- May perform other assigned tasks as required
9
Clinical Trial Associate Resume Examples & Samples
- Clinical study team member: works closely with the Clinical Trial Manager (CTM) and is responsible for coordination, tracking, and management of logistics in support of clinical trials
- Works closely with CTM, Study Start Up and legal to review and approve clinical trial agreements and site specific study budgets
- Supports and/or tracks external access rights to Clinical Trial Management Systems
- In conjunction with clinical operations team, manages and tracks clinical and non-clinical supplies required for distribution during study start up
- Supports tasks related to data management
- Reviews clinical trial documentation including monitoring visit reports, study plans, communication plans, timelines, informed consent templates etc
- Responsible for set-up, maintenance, reconciliation, and archiving of electronic Trial Master Files. Coordinates TMF transfer with CROs
- Works with CRO and Study Start Up to collect and review essential regulatory documents prior to site initiation/study drug release
- Participates in user acceptance testing (UAT) for IWRS
- Responsible for agendas and meeting minutes for clinical study team meetings
- Assisting in the routing, tracking, and coordinating site and CRO/vendor Confidential Disclosure Agreements (CDAs), contracts and change orders with Associate Director Clinical Operations, legal, and finance departments.Responsible for facilitating site advertisement review and approval with CCC Committee
- Responsible for special projects supporting operations/departmental initiatives such as ClinicalTrials.gov, SOPs, GCP, process enhancements, Sunshine Act, systems implementation, training, etc
- Bachelor’s degree or equivalent undergraduate degree
- Experience: 3-5 years clinical research experience in a pharmaceutical/biotech, CRO setting
- Solid knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
10
Clinical Trial Associate Resume Examples & Samples
- Reconciliation for phase 1-3 active and legacy studies (i.e., inventory, reconciliation and resolution of any deficiencies)
- Ensure TMF completeness and accuracy based on SOP's and Regulatory requirements
- Defines TMF issues and works with manager to resolve problems
- Experience with Good Documentation Practice and ICH/GCP compliance
- Understanding of records management
- Understanding of drug development and clinical operations
- Can locate information quickly and resourcefully
- Can manage assignments independently to meet timelines/milestones
- Completes other tasks as delegated by team leader
- Provides supervisor with feedback, input and perspective on TMFs
- Able to work with little instruction on routine work
- 1-2 years experience from similar work within a pharmaceutical company or CRO is preferable, but can also have experience other relatable experience in a different industry
11
Clinical Trial Associate Resume Examples & Samples
- You will need to ensure high levels of accuracy when completing tasks, you will set up, manage and maintain clinical study documentation and coordinate the ordering, dispatch and tracking of study materials. You will support the project teams by updating the Clinical Trial Management Systems
- You will possess sufficient administrative experience within a busy environment where you have demonstrated excellent organisation and prioritization skills or hold a bachelor’s degree in a science related field. Your experience of prioritising a demanding workload and ability to produce work to tight deadlines will be essential for this role
- You must possess previous working knowledge of Word, Excel, Outlook and PowerPoint
12
Senior Clinical Trial Associate Resume Examples & Samples
- Provide operational input on development, management and maintenance of study deliverables
- Use performance metrics and quality indicators to assist the clinical trial manager in driving study execution
- Lead / Participate in monitoring visit report review process
- Support Health Authority inspections and CQA audits as required
- Ensure full compliance of the required data in study management tools
- Proactive identification of potential risks and development/implementation of actions
- Develop and maintain collaborative relationships with internal and external partners/stakeholders
- Participate in vendor specification development and management/oversight
- Manage TMF set-up, ongoing quality review, and final reconciliation
- Reconcile IP at study level
- Actively contribute to study meetings including presentation subject matter expert, generate, finalize and distribute study team agendas and meeting minutes…)
- Contribute to development / coordination of study training
- Contribute to ordering and distribution of materials as required
- Manage study-level IP shipment to sites
- Manage collection, review and tracking of study documents as necessary
- Assist with Investigator meeting coordination and planning
- Assist with compilation of Clinical Study Report appendices
- Assist with maintenance of study budget tracking tools and reconcile invoices
- Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives
- Degree in a relevant discipline with experience in the Clinical Trial environment (CRA plus in-house experience bonus)
- Demonstrates analytical approach and anticipation of problems
- Strong knowledge of MS applications
- Knowledge of drug development process
13
Senior Clinical Trial Associate Resume Examples & Samples
- Clinical project team member: works closely with the Clinical Program Manager and is responsible for oversight and execution of assigned clinical studies, timelines, and key deliverables
- Clinical Study Team leader: Coordinates and participates in internal and external cross-functional clinical team meetings; serves as main point of contact study-level status updates
- Provides oversight and mentorship to Clinical Trial Associate(s) assigned to trials
- Participates in selection of CROs and vendors, RFP process, contract and budget negotiations
- Responsible for developing, maintaining and tracking study budgets and financial reporting, including invoice and PO management/reconciliation, accrual tracking and reporting, and re-forecasting, with Finance and Project Management
- Supports tasks related to data management, participates in database creation and user acceptance testing, input for edit checks and monitoring guidelines, data cleaning activities between study sites, data management and field monitors
14
Senior Clinical Trial Associate Resume Examples & Samples
- Identifies gaps and provides constructive feedback and solutions
- Basic understanding of project management desired
- Knowledge of study tools including electronic system skills such as CTMS / EDC
15
Clinical Trial Associate Resume Examples & Samples
- To handle all study related administrative taks by utilizes technology effectively to support the clinical trial development processes with the use of Clinical Trial Management System at the Protocol, Country and Site level
- Ensure that any clinical trial databases/ tracking tools are set up and maintained throughout the trial
- Collaborate with the study project team to reach target within set timelines
- Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study
- Set up and maintenance of the Trial Master Files, Electronic filing systems/ set up of the Investigator Site File
- Coordinating archiving of study documentation
- Managing and maintaining study documents & trial supplies e.g.; Patient Information Sheets, Patient Diaries, Lab Kits and Medical equipment for sites and re-ordering supplies
- Preparing essential clinical trial documentation, distributing, tracking and filing of documents. on return
- Understands basic financial analysis of a clinical trial budget and has the ability to track and manage study related contract and payments
- Effectively uses available tools and systems to gather information needed to manage study activities and to provide feedback to the appropriate BMS team members
- Identifies potential issues and suggests resolutions. Answers and resolves routine questions independently
- University Degree or equivalent in health sciences, nursing or pharmacy or related field
- At least 2-3 years of experience as CTA in Clinical Research or in the Pharmaceutical Industry
- Knowledge of the Industry/Clinical trial process and drug development and of ICH GCP
- Experienced in multitasking and prioritizing
- Excellent organisational skills and good attention to detail
- Ability to decision making, problem-solve, providing contingency plans
- Able to work with flexibility and independently
- Experienced with IT-technology as e.g. word-processing, presentation graphic, spreadsheet, database, and file management. (ARIBA, ECLIPSE, SAP)
- Good verbal and written communication skills (both in Swedish and English)
16
Lead Clinical Trial Associate Resume Examples & Samples
- Solid experience in pharma/CRO/healthcare
- Solid knowledge of drug development process
- Intermediate knowledge of ICH/GCP and local guidelines, regulations and directives
- Offer suggestions and contributes to discussion regarding milestones and deliverables
- Advanced computer technical skills
- Working knowledge of budgets, finance and clinical trials
17
Clinical Trial Associate Resume Examples & Samples
- Bachelor’s degree or equivalent from an accredited college or university is required; Life Sciences degree preferred
- 3+ years’ of health sciences experience is required (pharmaceutical industry or related experience is preferred; work in the areas of contracts, budgets, clinical operations, and/or project management a plus)
- Knowledge of the pharmaceutical business and ability to anticipate environmental changes and trends and implement changes accordingly; familiarity with medical terminology is necessary
- Ability to develop and track a variety of diverse project budgets and identify key performance indicators, in a fast-paced, changing environment
- Proficiency using Microsoft Word, Excel and PowerPoint; Microsoft Project is a big plus
- Understanding of finance principles and applies to managing project budgets
- Excellent oral and written English communication skills
- Ability to present financial and technical information in a concise and clear manner
- Experience in various electronic data capture systems involving site enrollment and tracking is a plus
18
Clinical Trial Associate Resume Examples & Samples
- Clinical project team member: works closely with the Associate Director, Study Start Up and is responsible for coordination, logistics, tracking and administrative tasks in support of clinical study start up
- Supports and tracks study start up status and metrics, for assigned clinical projects
- Responsible for data entry into Clinical Trial Management Systems, including Investigator databases, and/or other systems as required
- Interacts with CROs, vendors, clinical sites, monitors and other external partners to provide information and resolution for specific requests and issues
- Assists with and/or responsible for agendas and meeting minutes for clinical start up meetings
- Assists with logistics coordination for investigator meetings and external vendor meetings, as needed
- Responsible for review of site- and/or country-specific clinical trial budgets, with supervision by Associate Director, Study Start Up and/or clinical project team
- Research country-specific clinical trial laws and regulations, upon request, in order to provide resources or information to Associate Director Study Start up and/or clinical project team
- Coordinate with clinical operations project team on set-up of Trial Master File systems
- Responsible for special projects supporting operations/departmental initiatives such as ClinicalTrials.gov, SOPs, GCP, process enhancements, outsourcing, Sunshine Act etc
- Bachelor’s degree or equivalent undergraduate degree with science or healthcare experience preferred
- Experience: 1-2 years clinical research experience in a pharmaceutical/biotech, CRO setting preferred
- Basic knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
- Adaptable to changing priorities, excels in fast-paced environment
19
Clinical Trial Associate Resume Examples & Samples
- Oversee clinical supplies and distribution to sites. Communicate with sites on issues escalation related to clinical supplies
- Prepare, collect and provide support to sites on essential document collection and maintenance
- Coordinate the set-up, organization, maintenance, and close-out of Trial Master Files (electronic and paper)
- Coordinate the quality control reviews (QC), final reconciliation and archival processes for study documents/plans and Trial Master File
- Prepare and submit central IRB submissions and communicate with the IRB. Provide support to sites for site and local IRB submissions
- Coordinate with Recruitment Management regarding advertising submissions to IRB
- Prepare Drug Release Authorization forms and collect required documentation
- Develop, data enter, and maintenance of study tracking databases/logs (i.e. Start-up, feasibility/site selection, Monitoring, vendor activities etc.)
- Coordinate tracking and uploading monitoring visit documents including Monitoring Visit Reports, confirmation/follow-up letters in TMF
- Prepare materials (eg, binders, agendas, meeting minutes) for Investigator Meetings (IM), Kick-Off Meetings (KOM), and Face to Face Meetings (FTF)
- Performs data entry into the CTMS system for study or client information
- May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
- Perform administrative tasks to support team members with clinical trial execution as needed
- General knowledge of applicable clinical research development, regulatory requirements; including GCP and ICH guidelines and competent authority
- Strong Computer skills including proficiency in use of Microsoft Word,
20
Clinical Trial Associate Resume Examples & Samples
- Assist in the successful and timely progress of all clinical operations
- Assist in the development, implementation, and maintenance of Clinical Trial Master File, as needed
- Ensure all drug and supply requests are promptly filled (if applicable)
- Prepare patient trackers and meeting agendas as directed
- Coordinate the scheduling of all trial-related conference calls
- Assist the VP of Clinical Operations in the creation and maintenance of internal policies and SOPs as well as policies intended to assist researchers in maintaining compliance with research standards and guidelines
- Ensure adherence to protocols and compliance with GCP, ICH, GMP, and regulatory guidelines
- Participate in global research activities such as creating tools & training materials
- Prepare reports, documents, statistical surveys and other such data, as required
- Provide support to other individuals, as needed
- Requires a BS degree in a scientific discipline with at least 2 years of clinical operations exposure in the pharmaceutical industry and/or CRO; or equivalent healthcare experience
- Proven experience in a fast-paced biotechnology environment undertaking multiple early phase clinical trials is preferred
- Requires basic knowledge of pharmaceutical and biologic clinical Phase I-III trials with a strong emphasis on early development trials
- Effective communication with physicians, fellow employees, patients, guests, contractors and vendors
- Excellent MS Office applications skills, especially well-versed in the use of Excel spreadsheets and PowerPoint
- Attention to details; ability to maintain confidentiality and security
- Experience and success working in a busy team environment under high pressure
- Flexibility in a growing organization
21
Clinical Trial Associate Resume Examples & Samples
- Develop and maintain a good working knowledge of FDA, ICH/GCP requirements and relevant local regulatory
- Take personal responsibility for the quality of work, meeting required quality and performance standards and
- Conduct additional tasks as may be required from time to time by the Clinical Research Director/Clinical Research
- Advance in written and spoken English
- Computer Literature: Good Knowledge at user level of Microsoft Office. Proficiency in Microsoft applications
- 1+ year experience as a clinical Trial Administrator or in a Clinical Research & Development
22
Intern, Clinical Trial Associate Resume Examples & Samples
- Support initiatives including, assisting with newly implemented clinical trial electronic document storage system
- Prepare electronic documents (external and internal) with appropriate file names
- Upload documents into electronic document management system (Documentum, D2/eTMF)
- Draft clinical trial correspondence for CRA to send to Investigators and clinical sites
- Track the status of Monitoring reports from monitoring visit through final sign-off
- Review Clinical Study Reports for compliance with applicable format and style guides
- The successful candidate will have preferably completed a minimum of their sophomore year and be currently enrolled in an accredited college or university in a healthcare, scientific or psychology degree program, or a related field of study. A minimum 3.0 GPA is strongly preferred, however, a combination of experience and/or education will be taken into consideration
- Knowledge of Good Clinical Practices (GCP) and clinical trial research preferred but not required
- Must possess excellent computer skills to include MS Word, MS Excel, Adobe and familiarity with MS Access
23
Clinical Trial Associate, Outsourcing Resume Examples & Samples
- Supports ClinOut& Fin Sr. CTA with collection of financial documentation supporting contract milestones, Sarbanes-Oxley compliance, accruals and monthly financial reconciliation
- Supports ClinOut& Fin Sr. CTA, Director, and Clinical Ops CTMs in month end clinical project accrual reporting and reforecasting efforts in support of the clinical projects
- Work cross functionally on reporting enhancements and process improvements
- Support ad-hoc projects as required
- Financial contract review support and in gathering month end financial reporting from CROs/Vendors
- Works collaboratively with clinical team on month end reconciliation
24
Senior Clinical Trial Associate Resume Examples & Samples
- Coordinate with internal and external resources to develop project-specific recruitment plans and manage the production of project-specific promotional materials
- In conjunction with clinical project teams, support selection of and manage recruitment / retention vendors, and support the development of recruitment strategies, branding, and campaign concepts
- Coordinate and support internal recruitment-specific meetings to identify trends, share lessons learned, and deploy process improvements or new strategies to ensure best in class recruitment / retention campaigns across Alkermes’ studies
- Support the production of all advertising content
- Work with internal, cross-functional team to ensure all materials (central and site-specific) are reviewed and approved by the required internal team, relevant functional areas and committees
- Ensure all promotional materials are submitted, reviewed and approved by the appropriate ethics committees and health authorities
- Facilitate changes to recruitment materials
- Coordinate with CRO representatives to disseminate materials from central recruitment campaigns to clinical sites, and ensure the utilization of materials is in-line with expectations
- Work with investigator site representatives, CROs, and other vendors to develop recruitment plans and to facilitate the creation and review of site-specific recruitment/retention materials
- Track and report trends across sites, studies, and programs including but not limited to
- Overall return on investment and campaign effectiveness
- Enrollment metrics
- Cost/budgetary forecasting and tracking
- Vendor and site performance metrics
- Ensure appropriate information on recruitment trends is available in the Investigator database, and / or other clinical tracking systems / databases
- Support development of standard operating procedures (SOPs), training guides and other user reference material related to clinical recruitment and retention. Provide training to department staff and other team members involved in recruitment/retention strategies, including vendor partners, as needed
- Other Clinical and Start-up Related Tasks
- Maintains access rights to all required clinical systems, inclusive of e-TMF, Investigator Database, CTMS (Clinical Trial Management Systems), and any other systems, as needed
- Attends appropriate clinical study team meetings, and reports on progress in promotional materials
- Bachelor’s degree or equivalent undergraduate degree preferred
- Experience: minimum 2 years relevant experience in a pharmaceutical/biotech, CRO, site and/or patient recruitment agency setting, with prior experience in the implementation of patient recruitment activities
- Solid knowledge and understanding of GCP/ICH Guidelines
25
Clinical Trial Associate Resume Examples & Samples
- Assist with documents during study start-up including CDAs and CTAs
- Assist with compilation of regulatory documents
- Track incoming and outgoing regulatory packages
- Assist in organization of Investigators’ Meetings
- Assist with patient tracking to document patient visits and overall study progress
- File essential documents and maintain the TMF
- Track CRFs
- Coordinate investigator payments for studies where the Sponsor is responsible for this activity. Verify investigator payment details submitted for payment by CROs for studies where CROs are responsible for this activity
- Support Clinical Project Manager / Associate Director with meetings, including preparation of agendas and minutes and tracking action items
- Distribute trial-related materials to study sites
- Support preparation and subsequent distribution of newsletters
- Prepare Study File Notebook for review by study team
- Create and maintain tracking tools to monitor collection and expiry of essential documents; work with CRO team to obtain required updates
- Create and maintain the Trial Master File and electronic workspace (Sharepoint) for each study and the program. Ensure that all essential study documents are tracked and filed in a timely manner
- Prepare, distribute, file, and archive clinical documentation and reports
- Review study files/TMF periodically for accuracy and completeness
- Review site regulatory and essential documents to approve initial drug shipment
- Assist with essential document reconciliation at study end
26
Clinical Trial Associate Resume Examples & Samples
- Assist Clinical Operations and Medical and team
- Excellent verbal, written, and interpersonal skills
- 1+ year Clinical Operations experience
- Strong communication skills (verbal and written)
- High initiative and self-starter attitude
- Ability to operate in a fast-paced environment
- Adaptable and flexible to a growing company
27
Clinical Trial Associate Resume Examples & Samples
- Clinical project team member: works closely with the Clinical Trial Manager (CTM) and is responsible for coordination, logistics, tracking and administrative tasks in support of clinical trials
- Responsible for tracking study budgets, including invoice and PO management/reconciliation, and accruals in support of the CTM and Finance
- Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects
- Responsible for set-up, filing, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files
- Responsible for data entry into Clinical Trial Management Systems
- Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific requests and issues
- Manage and track clinical and non-clinical supplies
- Assists CTM with agendas and meeting minutes for clinical sub-team meetings
- Assists CTM with logistics coordination for investigator meetings and external vendor meetings
- Responsible for routing, tracking, and coordinating site and CRO/vendor Confidential Disclosure Agreements (CDAs) and contracts with Sr. Manager Clinical Operations, legal, and finance departments
28
Senior Clinical Trial Associate Resume Examples & Samples
- Assist in the development and implementation of recruitment strategies to increase patient recruitment into the trial (eg investigator meetings, update newsletters, drug accountability and delivery to investigational sites)
- Work with the CRA and SM to update the CTMS and other trackers – which includes site status, details of patient recruitment into clinical trials, each individual’s progress through the trial, payments due to investigators, total paid to site, adverse events and other relevant patient related information (management of Clinical Trial Management Software)
- Maintain a database that records details of clinical trial shipments, and in collaboration with the CRA ensure that there are adequate supplies of clinical trial material to meet project needs. Plan, order and distribute non-drug clinical trial supplies eg clinical report forms, diary cards
- Assist the SM with oversight of lab kits supplies to the sites
- Assist the CRA during the preparation for the investigator study initiation visit
- Can support the study team with the submission of clinical trials to ethics committees and competent authorities (either in Spain and in other countries) and responsible for reviewing investigators’ contracts
- Maintain Trial Master File up-dated. Performs ongoing review of the TMF
- Fulfill all responsibilities in accordance with Celgene SOPs / WPs and policies
- Develop and maintain a good working knowledge of FDA, ICH/GCP requirements and relevant local regulatory requirements
- Participate in and contribute to Clinical Research meetings, study related meetings, training activities and cross-functional activities as appropriate
- Contribute to general departmental administration and the development and continuous improvement of departmental procedures
- Maintain and facilitate effective and productive communication and working relationships with all members of the department and staff in other functions
- Conduct additional tasks as may be required from time to time by the Clinical Research Director/Clinical Research Manager
- Keep Celgene Tracking databases up to date and enter study information into National Clinical Trial Database where appropriate
- Design and maintain contracts & administrative tracking tools
- Support the production, coordination, completeness and accuracy of EC submissions in order to guarantee Celgene studies are submitted and approved in a timely fashion (for studies monitored in house)
- Customize contracts to local requirements as applicable
- Support/Perform Research Contract negotiations (in English & local language, where appropriate ) with Hospital/Institution, Central Contracts & Out-Sourcing Group, and Celgene’s Legal Group, to ensure local Start Up timelines are adhered to
- Track Site payments to ensure timely payments are reflective of the contract’s schedule
- Develop and maintain a good working knowledge of relevant protocols
- Support Clinical Team (e.g. office or home based, and the contract CRAs) in administrative tasks and logistical support related to R&D Studies
- Manage study material and study supplies, as applicable
- Organize local Investigator Meetings, including agendas and minute production
- Liaise closely with the CRAs, Study Managers team and CTAs
- May conduct data query resolution and SAE information collection via facsimile, mail and telephone
- Manage local translators & printers for required local documents
- Distribute documents to investigational sites, ECs, or vendors as per requirements and distribute of communications and study documents to study teams. These might be single documents or packages and may be safety [submissions, safety letters (SUSARs), Investigator´s Brochures, or Annual Safety Reports] or study (listings, trackers, essential TMF documents) related
- Participate in SOP and WP development and contribute to process initiatives as required
- Mentor and coach other CCTAs, as appropriate
- Produce regular and adhoc Clinical Operations status reports as required
- Act according the Manual of Good environmental practices and segregate waste materials of the job properly
- Degree in administration or relevant education or comparable operating experience
- Computer Literature: Good Knowledge at user level of Microsoft Office. Proficiency in Microsoft applications: Outlook, Word, Excel etc
- Good database and data manipulation skills/ knowledge
- Knowledge of ICH / GCP and regulatory guidelines/directives
- 5+ years experience as a clinical Trial Administrator or in a Clinical Research & Development
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Clinical Trial Associate Resume Examples & Samples
- Help manage clinical, regulatory and study-related essential documents such as study protocols, Case Report Forms, Informed Consent Forms etc.; review documents for completeness, accuracy and compliance with protocol and appropriate regulations. Identify issues and take appropriate corrective action as necessary
- Interaction and communication with investigator sites. Collection of relevant documentation, provision of study materials / documents
- Liaise with contract organisations, vendors and other suppliers of project support services to ensure study deliverables are met. Contribute to documentation, processes and set-up activities to facilitate efficient working and effective partnerships with external groups
- Provide input on agendas, create materials, and liaise with meeting planners / coordinate logistics for key meetings; e.g. internal meetings or external investigator meetings
- Help ensure accuracy of clinical trial management databases and resource/budget tracking tools, providing information, maintaining meeting minutes and following up on questions as necessary. Help check for discrepancies and take actions to correct as necessary
- Identify areas for process or technology improvements with regard to tasks undertaken within the role
- Assist in the ordering of clinical trial supplies
- Assist in the compilation of the Clinical Study Report and its appendices
- In collaboration with the Trial Document Specialist responsible for setting up and maintaining Trial Master Files and ensuring all relevant study documents are filed and archived based on the appropriate guidelines
- Audit existing Paper Trial Master Files, collect outstanding documents and archive after study is completed
- Assist the CS in organizing investigator/site initiation meetings and/or first dose/monitoring visits
- Maintain knowledge of ICH-GCP, external regulations and procedures, and supplement by training and practice of Novartis SOPs and internal policies
- Must possess at least 1 year of direct experience supporting early phase clinical studies within a Pharma/Biotech environment
- Demonstrated organizational skills and interpersonal skills
- Good interpersonal skills, ability to successfully interact with a wide range of people
- Ability to work in a team as well as independently if required and to manage multiple priorities with support
- Office and clinical trial software IT computer literacy