WHAT DOES A CLINICAL TRIAL ASSOCIATE DO?
Updated: Nov 26, 2024 - The Clinical Trial Associate liaises between the site and the company, ensuring trial start-up activities meet timelines and quality standards. Responsibilities include reviewing clinical documents, preparing trial dossiers for approvals, and establishing trial budgets. Tracks and archives study startup activities, and facilitates communication between budget officers, site staff, and relevant parties to support the clinical trial process.
A Review of Professional Skills and Functions for Clinical Trial Associate
1. Clinical Trial Associate Duties
- Data Review: Assists the CSM in the review of data to support study-related payments.
- Performance Tracking: Supports the tracking of key study performance information and cycle time metrics pertaining to time, cost, and quality deliverables, e.g., study start-up metrics, enrollment, data collection timeliness, etc.
- Site Feasibility: Supports the collection of site feasibility data, enrollment projections, and site identification activities.
- Document Development: Assists in the development of the core study documents, plans, and processes.
- Procedure Adherence: Adheres to internal procedures for study planning, study conduct, close-out, and reporting.
- Start-Up Support: Supports study start-up activities ensuring that essential site documents are collected, and sites are initiated per the study plan.
- Activity Tracking: Tracks site initiation and enrollment activities at the country and site level.
- Personnel Management: Participates in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.
- Data Coordination: Coordinates and participates in data reviews in conjunction with CRO/Data Management staff.
- SOP Review: Participates in the review and revision of departmental SOPs, and provides support to establish and maintain operational infrastructure.
2. Clinical Trial Associate Details
- Study Management: Manage clinical research studies with a low number of active patients on treatment and those with only patients in follow-up.
- Communication: Communicate with sponsor/CRO and sites regularly as the main point of contact for all questions related to protocol, billing, monitoring issues, and USO central processes.
- Amendment Submission: Responsible for submitting amendments timely and monitoring progress for compliance with other support teams to ensure data is completed and accurate.
- Paperwork and Payments: Work with internal departments to ensure all paperwork and payments are completed in order to close a study.
- Study Closure: Prepare and administer materials to close out studies that have met all requirements.
- Form and Tool Management: Create, modify, maintain, and distribute study forms and tools to research sites including but not limited to clinical trial information sheets and training documentation.
- Monitoring Training: Responsible for the overall sponsor/CRO monitoring training for clinical research.
- Monitor Setup: Assist with getting new monitors set up, log-in and passwords, password resets, and follow-ups on completion.
- Tracking and Metrics: Track across all sponsors/CRO as well to be able to provide metrics to support sites.
- CTA Training: Responsible for training all new clinical trial associates.
3. Clinical Trial Associate Responsibilities
- Document Collection: Ensure the collection and maintenance of essential documents for the TMF to ensure GCP compliance.
- eTMF Management: Organize and maintain Veeva electronic Trial Master File (eTMF) and assist with eTMF administrative support activities and resolution of QC findings.
- Operations Support: Provide day-to-day clinical operations support.
- Protocol Deviation Tracking: Track items related to protocol deviations.
- Study Management: Assist to ensure that the studies are managed and executed in accordance with ICH GCP, regulations, the protocol, and company SOPs.
- Document Review: Facilitate the review of documents with internal and external teams.
- Action Item Follow-Up: Assist with follow-up of outstanding action items until resolution with internal team, CRAs, and vendors.
- Technical Support: Provide technical support by tracking ancillary clinical supplies and other trial-related documents and materials.
- List Maintenance: Create and maintain vendor contact lists as well as other internal lists.
- Data Entry: Perform and/or maintain data entry in the internal Veeva Vault.
- Communication: Assist in communication with investigative sites and external vendors (e.g., Central Lab).
- Trial Updates: Assist in the preparation of trial updates and presentations.
4. Clinical Trial Associate Accountabilities
- Point of Contact: Acts as a point of contact between the site and the company for the trial start-up activities at the responsible site(s) or country(ies) within specific timelines and quality standards.
- Document Review: Review and validate the clinical essential documents submitted by the sites.
- Dossier Preparation: Prepare the clinical trial dossier to obtain approval from the Ethics Committee and Health Authority in the responsible country(ies).
- Milestone Liaison: Liaise with the clinical team member or project manager on the project start-up milestone/timeline, which includes but is not limited to IRB approval, import license approval, and other key milestones.
- Startup Tracking: Ensure the study start-up activities are appropriately tracked and the essential documents have been uploaded to/archived by an appropriate system.
- Budget Establishment: Establish the clinical trial budget between the sites and the company.
- Meeting Facilitation: Facilitate the meeting between the budget/contract officer and the site staff.
- Party Liaison: Liaise with internal and external parties where necessary to ensure the smooth startup of the clinical trial activities.
- Additional Duties: Undertake other reasonably related duties as may be assigned from time to time, in order to meet business and clients’ needs.
5. Clinical Trial Associate Tasks
- Trial Management: Supports the Clinical Study Manager (CSM) in the management of clinical trials while upholding study timelines and milestone deliverables.
- Data Entry: Performs data entry and maintains the Clinical Trial Management System (CTMS).
- Meeting Participation: Participates in study team meetings, including drafting of agendas, minutes, and other meeting materials.
- Document Management: Manages trial-related documents in the Trial Master File (TMF).
- Document Review: Reviews documents for completeness, accuracy, and compliance with protocol, applicable regulations, and SOPs.
- Audit Preparation: Prepares for periodic audits and follows up on the resolution of open issues to ensure study team members are compliant with documentation and the use of required systems, e.g., eTMF, CTMS, etc.
- System Champion: Acts as system ‘Super user’ championing the proper use of relevant clinical systems.
- Supply Tracking: Tracks delivery and receipt of required study supplies and materials to study sites.
- Meeting Support: Supports investigator meeting preparation and the collection/distribution of materials.
- Training Participation: Participates in the training of study team members and investigative site staff.