WHAT DOES A CLINICAL RESEARCH ASSISTANT DO?
Updated: Dec 10, 2024 - The Clinical Research Assistant identifies and recruits study-eligible patients, obtains informed consent, and maintains documentation of patient registration. This role involves conducting protocol management, ensuring compliance, and handling protocol-related specimen procurement and data management. The assistant also establishes and maintains relationships with patients and staff, ensuring confidentiality, and manages orders for the research lab.
A Review of Professional Skills and Functions for Clinical Research Assistant
1. Clinical Research Assistant Duties
- Clinical Research Protocol Knowledge: Be knowledgeable about clinical research protocols and protocol requirements.
- Inventory Management: Maintain inventory of supplies, reorder study kits, and other supplies.
- Clinical Area Stocking: Ensure clinical research areas are stocked.
- Team Communication: Meet weekly with the entire study team and communicate with the team to ensure efficient operations.
- Patient Data Review: Review patient data to determine appropriate eligibility and deficiencies regarding enrollment into clinical trials.
- Patient Interaction: Greet study subjects and consent patients before procedures.
- Specimen Handling: Procure and process human biological specimens (including blood, urine, etc.) in adherence to protocol parameters and appropriate training.
- Data Entry and Chart Review: Perform data entry and chart review/abstraction to verify that key data has been reported to the clinical research database or reported to the sponsor in the required format.
- Data Clarification Review: Review follow-up data clarifications or data queries and report within the study timeline.
- Subject Data Maintenance: Maintain and update subject data for study analysis and survival.
- Data Retrieval Assistance: Assist investigators with any special requests for data retrieval and/or evaluation and analysis of clinical data for ongoing research studies.
- Continuing Education: Participate in continuing education activities within the research program and other areas to maintain current knowledge of disease processes, research regulatory requirements, and process improvements for clinical trials.
2. Clinical Research Assistant Details
- Recruitment Support: Assist with recruitment, screening, and scheduling of potential study participants.
- Data Management: Assists with collection and entry of data into study case report forms and/or electronic data capture system and responds to queries on time.
- Document Submission: Collect and assist with the submission of study-related documents, study protocols, and study protocol amendments for submission to the IRB per policy and procedure.
- Documentation Accuracy: Maintains accurate and complete documentation of signed informed consent and HIPAA Authorization forms, relevant IRB approvals, source documentation, and study-related communication.
- Specimen Handling: Collect, process, and ship potentially biohazardous specimens.
- Test Administration: Administer structured tests and questionnaires according to research study protocols.
- Technology Utilization: Utilize study-related technology and equipment as part of data collection procedures.
- Material Preparation: Gather and prepare study-related materials for participants' visits.
- Organizational Skills: Demonstrate effective organizational, planning, and prioritization skills.
- Communication Distribution: Assist in the distribution of communications, recruitment packages, etc. to and from study sites.
- Enrollment Tracking: Assist in the tracking, filing, and distribution of weekly updates of subject enrollment logs from the study sites.
- Document Review: Review and preparation of essential study documents e.g. Patient Information and Informed Consent Form.
- CRA Schedule Monitoring: Monitoring of the CRA visit schedule.
3. Clinical Research Assistant Responsibilities
- Implementation and Data Entry: Participate in the implementation and data entry for registry and clinical trials.
- Patient Screening and Recruitment: Participate in patient screening, recruitment, enrollment, and follow-up of assigned clinical trials.
- Informed Consent and Randomization: Obtain informed consent, randomize patients according to protocol, schedule patient visits/tests, and assess/document toxicities and adverse effects.
- Compliance Assessment: Assess patient compliance with study procedures and report any deviations to the Clinical Research Coordinator.
- Documentation Maintenance: Maintain source documentation files.
- Investigator Support: Support the activities of the principal investigators/sub-investigators.
- Quality Assurance and Performance Improvement: Participate in the development and management of quality assurance and performance improvement activities within the program.
- Organizational and Planning Skills: Demonstrate effective organizational, planning, and prioritization skills.
- Communication and Recruitment Assistance: Assist in the distribution of communications, recruitment packages, etc., to and from study sites.
- Enrollment Log Management: Assist in the tracking, filing, and distribution of weekly updates of subject enrollment logs from the study sites.
- Co-monitoring Activities Coordination: Coordination and performance of co-monitoring activities.
4. Clinical Research Assistant Accountabilities
- Appointment Scheduling: Work with the PI and/or medical facilities to schedule and coordinate appointments for the medical procedures necessary for the clinical research project.
- Document Management: Manage consent forms, case report forms, and other documents necessary for HIPAA compliance and clinical trial compliance.
- Filing Systems: Manage secure filing systems in electronic and paper format necessary to conduct the research.
- Financial Tracking: Work with appropriate personnel in Finance to track expenditures and request invoicing of the sponsors of clinical research projects.
- Team Collaboration: Work cooperatively with others and accept direction from the PI, Finance, and the Vice-Chair.
- Schedule Management: In charge of keeping track of exacting schedules of mailouts and returns of study equipment to research subjects with chronic fatigue syndrome.
- Package Preparation: Prepare mailout packages that involve downloading data from heart monitors and actigraphs and initializing these devices for re-use by study subjects.
- Participant Interaction: Interact directly with study participants via phone calls to conduct study procedures (e.g., screening interviews, walk tests), monitor their progress in studies, and troubleshoot any problems.
- Data Integrity: Assist with maintaining the integrity of collected data in an electronic database and assist with maintaining the study protocol documents and compliance with all Institutional Review Board policies.
- Specimen Processing: Screen and assist consenting study subjects and help process/ship lab specimens.
- Data Collection: Interact with study subjects when screening, recruiting, and collecting data.
- Training Participation: Attend and participate in required training for the role.
5. Clinical Research Assistant Roles
- Patient Identification and Recruitment: Identifies study-eligible patients, recruits patients to study, and obtains informed consent.
- Patient Registration: Ensures consented patients are appropriately registered.
- Documentation Maintenance: Maintains documentation of patient registration.
- Protocol Management: Conducts protocol management for an assigned set of research protocols.
- Protocol Compliance: Ensures protocol compliance with intense monitoring of specific study requirements.
- Specimen Procurement: Ensures protocol-related specimen procurement.
- Specimen Tracking and Collection: Tracks, orders, and collects specimens for banking by study protocols, using appropriate or specified equipment for collecting and handling specimens.
- Proper Labeling: Ensures proper labeling and obtains pertinent clinical and protocol information on request forms.
- Data Management and Analysis: Performs data management and data analyses.
- Data Presentation: Creates graphs and presentations of data by the research study.
- Interpersonal Relationships: Establishes and maintains interpersonal relationships with patients, hospital personnel, and hematology physicians, nurses, and staff while assuring the confidentiality of patient information.
- Lab Supplies Management: Orders kits, reagents, chemicals, and biologicals for the research lab.