WHAT DOES A CLINICAL TRIAL ASSISTANT DO?
Updated: Nov 26, 2024 - The Clinical Trial Assistant tracks study essential documents and ensures the completeness of the Trial Master File for assigned clinical studies according to appropriate regulations. Supports ongoing use of CTMS by maintaining and tracking relevant activities and assists with logistics for Investigator meetings and expert panel meetings. Compiles accurate regulatory documents for submission to Health Authority at the country level and participates in project team meetings, providing status updates.
A Review of Professional Skills and Functions for Clinical Trial Assistant
1. Clinical Trial Assistant Duties
- Project Management: Supports the clinical team in the overall management of studies, including planning, execution, and closeout of multiple clinical trials
- Document Management: Manages the Trial Master File according to Sponsor Oversight plan to ensure accuracy, completeness, and currency
- Data Tracking: Creates and maintains study trackers (e.g., contact lists, study status trackers, enrollment) and project files
- Financial Administration: Assists the clinical team with maintenance and tracking of PO requisitions and invoices
- Metrics Tracking: Tracks metrics related to Sponsor Oversight
- Collaboration: Works closely with CRO monitoring staff, reviews site/patient activity tracking, reviews monitoring reports, and proactively identifies and solves study-related issues
- Regulatory Compliance: Reviews all essential regulatory documents prior to site initiation and Investigational Product release
- Supply Management: Assists in tracking investigational product supplies at the trial site level, keeping sites informed of trial supplies including drug lots/batches and expiration dates
- Safety Monitoring: Assists with safety data monitoring such as tracking of SAEs and reporting to collaborators
- Quality Assurance: Provides support in reviewing study documents (e.g., site ICFs, IBs, protocols, regulatory documents, SIV slides, etc.) to ensure quality and consistency
- Administrative Support: Supports with other study-related administrative tasks (scanning, emailing, filing, shipping, etc.)
2. Clinical Trial Assistant Details
- TMF Management: Involved in set-up and maintenance of study-specific Trial Master File (paper TMF or eTMF) including reconciliation and archival
- Document Tracking: Accountable for the timely tracking and review of essential study documents for assigned clinical studies, ensuring completeness, accuracy, and compliance with study protocols, company SOPs, GDPR, ICH-GCP, ISO 14155, and applicable local regulations
- Operational Support: Support and assist the team with critical operational aspects of the trial, such as site activation and site closure activities
- Regulatory Preparation: May be involved in the preparation and submission of study-related dossiers to CA and EC
- File Maintenance: Responsible for the setup and maintenance of study site files and study-related documents
- Data Entry: Support maintenance of the Clinical Trial Monitoring System (CTMS) or similar trackers by data entry of the applicable information upon receipt
- Meeting Organization: Support the organization of study-related meetings
- Communication: Liaise with study sites and establish good communication lines with various departments
- Translation Coordination: Coordinate translations of study documents
- Payment Coordination: Coordinate and follow up of site payments and vendor payments
- Invoice Processing: Support the review, processing, and tracking of invoices
- Process Improvement: Communicate and support process improvement initiatives
3. Clinical Trial Assistant Responsibilities
- Administrative Support: Responsible for providing administrative and technical support for the various tasks of the clinical trials
- Collaboration: Work closely with the Clinical Development and Research team to ensure the most effective and efficient conduct of the clinical trials by providing administration, communication, and project tracking support
- TMF Management: Assume primary responsibility for the setup, development, maintenance, and correspondence of the Trial Master File (TMF) for studies assigned
- File System Management: Set up and maintenance of electronic filing systems/setup of the Investigator Site File (ISF)
- Regulatory Tracking: Track Ethics/Regulatory submissions and approvals for studies
- Documentation: Prepare, distribute, track, and file essential clinical trial documentation
- Archiving: Coordinate archiving of study documentation
- Sponsor Document Management: Assist the clinical team in tracking and distribution of Sponsor study documents (e.g., protocols, administrative letters, and pharmacy manuals to clinical research organizations (CRO) and study sites
- Sample Logistics: Assist with the management of tracking and logistics for biological samples supporting clinical trials from collection to analysis to help ensure that sample inventories are accurate, complete, and up to date
- Vendor Management: Participate in vendor selection and management meetings (e.g., CROs, IVRS, Central Labs, etc.)
- Meeting Coordination: Support the clinical team with coordination and preparation for investigator meetings, PI calls, conferences, as well as internal clinical meetings
4. Clinical Trial Assistant Overview
- Document Tracking: Tracking study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations
- Issue Resolution: Assist study staff to quickly and effectively resolve issues relating to Study Files (Trial Master File)
- CTMS Support: Support ongoing use of CTMS by maintaining and tracking relevant activities
- Supply Management: May be asked to provide support for study supplies creation, ordering, and distribution to the sites
- Logistics Assistance: Assistance with logistics for Investigator meetings/expert panel meetings
- Regulatory Support: Supports the LTM in compiling accurate/complete regulatory documents for submission to Health Authority at the country level
- ICF Review: Upon request from LTM, reviews site-specific Informed Consent Form (ICF) for completeness to facilitate the approval of changes to mandated J&J language in collaboration with the legal department, and Contract and Grants Associate
- Project Updates: Participates in and presents status updates in project team meetings
- System Testing: User Acceptance Testing for various clinical systems
5. Clinical Trial Assistant Tasks
- Clinical Support: Support the Clinical Operations team in the successful execution of clinical trials from protocol concept to clinical study report, complying with Good Clinical Practice (GCP) guidelines and international regulations
- Meeting Coordination: Coordinate, provide setup, and attend project meetings including internal team and CRO/vendor meetings
- Tracker Management: Set-up, update, and maintain clinical trial-related trackers such as regulatory documents, startup progress, screening/enrollment, study invoices/payments, project budgets, etc.
- Equipment Coordination: Coordinate clinical trial equipment and supplies
- Regulatory Assistance: Assist with IRB/EC and regulatory submissions
- Document Tracking: Collect and track regulatory documents for the Trial Master File (TMF), and perform TMF reviews to ensure completeness and support inspection readiness activities
- Quality Review: Regularly review documents to ensure adherence to Clinical Operations and/or project-specific quality requirements (e.g., SOPs, work practices, training guides)
- Process Improvement: Assist with identifying and implementing best practices and continuous improvement plans