Job Description
Job Description
Job Description
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Clinical Research Coordinator
Job Summary
The Clinical Research Coordinator is responsible for coordinating research patient visits according to both the ICH-GCP guidelines and the IRB-approved study protocol and / or manual of procedures. Day to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time.
Duties / Responsibilities
Level I
- Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.
- Administer sponsor required questionnaires (i.e. VFQ)
- Works with team member responsible for ordering study supplies (lab kits, shippers, etc.) to ensure adequate inventory is on hand.
- Ensures study staff is properly trained on study-related information (i.e. protocol, ICF, manuals, etc.) and that the training is documented.
- Creates, manages, and maintains source documents for each trial.
- Attends teleconferences and investigator meetings as requested by research director.
- Reviews and comprehends all study protocols, e.g. study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
- Works with other members of the study team and clinical team to recruit eligible candidates to meet enrollment goals.
- Screens subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant’s eligibility accurately.
- Efficiently completes all study tasks delegated to them (i.e. scribing, VFQ, IOP, etc.).
- Collects updated medical history, adverse events and serious adverse events that need to be reported to the sponsor and IRB within the required timeframe.
- Conducts and / or participates in the informed consent process / discussion with research participants, including answering any questions related to the study.
- Assures that amended consent forms are appropriately implemented and signed.
- Acts as a secondary reviewer to provide oversight so that the ICF process is conducted accurately.
- Collects data as required by the protocol and enters information into the electronic data capture (EDC) system in the specified timeframe indicated in the study contract.
- Oversees data and ensures that it is being entered correctly and resolves any queries issued within the required timeframe. • Collects and reports ALL Adverse Events.
- Collects and reports ALL Serious Adverse Events.
- Responsible for ensuring all SUSAR / Safety Reports are acknowledged and reviewed.
- Coordinates monitor site visits and assists with preparation of site visit documentation.
- Works with the monitor site visits and assists with preparation of site visit documentation.
- Works with the monitor to make any corrections needed to meet requirements and deadlines as needed.
- Manages and maintains all regulatory information about the study including the protocol, investigator brochure, IRB documents, investigator disclosures, CVs, training documentation, instructions on reporting requirements for the IRB and sponsor.
- Obtain any applicable additional / required sponsor training and / or certifications.
Level II (in addition to Level I)
- Primary coordinator for multi-site studies within the practice.
- Primary sponsor lead for multi-sites within the practice.
- Reviews in-depth medical and / or hospital records for Serious Adverse Events.
- Is proficient in all aspects of the CTMS system (i.e. running reports).
- Mentors and trains research assistants and study coordinators.
Level III (in addition to Level I & Level II)
- Primary coordinator for multi-site studies within the practice.
- Provides leadership to the team.
- Travel to other RCA sites for mentoring and collaboration.
- Mentors and trains research assistants and study coordinators within practice.
Job Tags
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