WHAT DOES A CLINICAL RESEARCH ASSOCIATE DO?
Updated: Dec 22, 2024 -The Clinical Research Associate is responsible for planning, guiding, and reporting on clinical research studies while ensuring compliance with regulations and standards. This role involves managing multiple clinical studies/sites to ensure timely initiation, enrollment, and conduct, and supporting study development under the guidance of a Study Manager. This individual also leads project teams, provides input on study design and risk analysis, and develops and implements training plans for personnel.
A Review of Professional Skills and Functions for Clinical Research Associate
1. Clinical Research Associate Roles
- Protocol Documentation Maintenance: Maintains current and accurate consent and biospecimen protocol documentation.
- Protocol Change Notification: Notifies investigators and other team members of pertinent protocol changes.
- Data Compilation and Submission: Compiles and submits the long-term follow-up data on appropriate forms according to CIBMTR requirements.
- Consent Verification: Verifies consent for allogeneic patients and donors who are eligible for specimen collection per CIBMTR and COH corresponding protocol.
- Specimen Preparation and Shipping: Prepares and ships specimens for analysis to CIBMTR, using appropriate or specified equipment for collecting and handling specimens.
- Proper Labeling and Information Collection: Ensures proper labeling and obtains pertinent information on request forms.
- Adverse Event Management: Ensures timely, accurate collection of all adverse events, adverse reactions, and complaint reports, and implements follow-up.
- Progress Reporting: Prepares reports of study progress to the upper management.
- Clinical Site Documentation: Prepares and/or tracks required documentation for clinical sites (contracts, budgets, IRB documentation).
- Information and Data Support: Assists with information gathering, literature searches, data analysis, report generation, and creation of documents.
- Study Development and Maintenance: Assists with the development and maintenance of the study.
- Investigator Support: Assists with the preparation and execution of the Investigator.
2. Clinical Research Associate Tasks
- Specimen Processing Knowledge, Safety Practices: Develops and maintains knowledge of various aspects of processing specimens, paying particular attention to safety practices.
- Data Management: Works on special data management projects.
- Protocol Compliance, Physician/Nurse Collaboration: Works with physician or nurse to see that protocol-related tests and evaluations are ordered per protocol guidelines.
- Transplant Nurse Collaboration, Specimen Collection: Collaborates with transplant nurses to ensure timely consenting and specimen collection to avoid potential deviations.
- Protocol-Specific Duties: Performs protocol-specific duties per the research study.
- Quality Performance, Supervisor Collaboration: Works with supervisor to ensure performance of appropriate levels of quality.
- Issue Identification, Communication: Identifies and communicates important protocol and data management issues or problem areas to the supervisor.
- Professional Development: Maintains professional growth and development through seminars, workshops, and professional affiliations to maintain certification/licensure, and/or keep abreast of the latest trends in the field of expertise.
- Organizational Efficiency: Ensures the work environment is organized and functions efficiently.
- Meeting Participation: Attends and participates in meetings
- Staff Relief: Provides staff relief as required to meet the needs of the department.
- Documentation Management: Manages documentation issues with CROs and/or study sites.
3. Clinical Research Associate Overview
- Clinical Trial Management: Assist in overseeing TP Therapeutics’ clinical trials from initiation, planning, execution, maintenance, and close-out.
- Site Startup Activities: Coordinate investigational site startup activities, including the creation, preparation, and shipment of documentation (e.g., ICFs, CRFs, study manuals, study binders, etc.), Ethics Committee submissions and approvals.
- Informed Consent Form Review: Review site changes to ICFs, facilitate completion of clinical study agreements and budgets, and shipment of clinical supplies.
- Vendor Management: Coordinate contract vendors and Clinical Research Organization activities to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs.
- Invoice Review: Review invoices from vendors/consultants as per contract.
- Tracking System Maintenance: Coordinate and maintain relevant tracking systems for subject screening, enrollment, study visits, data entry, and query resolution.
- Remote Monitoring: Manage all aspects of the assigned clinical study activities on remote and site monitoring.
- Site Monitoring: Monitor the assigned study sites according to protocol regulations, SOPs, GCP, and ICH guidelines.
- Visit Reporting: Provide timely and accurate visit reports.
- Staff Training: Ensure that all the site staff involved in the study receive accurate instructions and tools to ensure patient safety and quality data.
- Site Initiation Visits: Participate in Site Initiation Visits.
- Co-Monitoring: Conduct co-monitoring visits to oversee CRO personnel and study conduct at the site.
4. Clinical Research Associate Functions
- CRF Review: Support in the review of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT.
- Meeting Planning: Assist in the planning of Investigator Meetings and/or Site and CRA trainings.
- Document Development: Assist with protocol, case report form, source document template development, internal SOP/guideline development, and final report preparation.
- Database Review: Review clinical databases on a real-time basis to identify/resolve data entry issues, and track the query process to identify/report evolving trends in the data.
- Sample Oversight: Coordinate the oversight of sample collection (i.e., tissue samples, lab samples, scans, PK samples).
- Document Coordination: Coordinate the exchange of TMF documents with external service providers as applicable and periodic reviews and QC of the Trial Master File to ensure audit and inspection readiness.
- Site Liaison: Serve as a liaison and resource for investigational sites.
- SOP Development: Participate in the development, review, and implementation of departmental SOPs and processes.
- Audit Assistance: Assist sites and the study team during audits/inspections.
- Study Partnership: Ensure study objectives and optimal study conduction by partnering with Study Management and other relevant stakeholders.
- File Management: Proactively manage the Trial Master File and Country File to required SOP and regulatory standards.
- Issue Resolution: Identify, escalate, and resolve all monitoring and regulatory issues in partnership with the investigator, site personnel, and study teams.
5. Clinical Research Associate Job Summary
- Regulatory Compliance: Plan, guide, and report on the conduct of clinical research studies within compliance with state and federal regulations, industry standards, and corporate policies.
- Study Management: Effectively manage multiple clinical studies/sites to ensure accurate and timely initiation, enrollment, and conduct while providing moderate-level study management support.
- Study Support: Under the support of a Study Manager, contribute to study development, conduct, and closure.
- Project Leadership: Lead project teams, providing input to study design, risk analysis, and clinical consultation relative to the therapeutic area.
- Document Creation: Create, review, and/or revise study documents, including but not limited to site-informed consent documents, monitoring plans, and annotated monitoring visit reports.
- Investigator Identification: Assist with identifying investigators/sites.
- System Training: Assist in testing and training the study team on clinical trial systems (e.g., electronic data capture systems or electronic trial master file systems).
- Training Development: Develop and implement training plans for personnel, including CRAs, CRA Assistants, and site personnel.
- Leadership and Monitoring: Provide leadership and monitoring support.
- Start-up Management: Responsible for study start-up activities including managing trial documents.
- Report Review: Review and approve completed monitoring visit reports.
- Results Review: Review study results with the study team and contribute to final reports.