Clinical Research Coordinator
The research coordinator is primarily responsible for coordinating research patient visits according to ICH-GCP guidelines, and according to 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.
- Reviews and comprehends all study protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
- Conducts and/or participates in the informed consent process/discussion with research participants, including answering any questions related to the study.
- Obtains appropriate signatures and dates on forms in appropriate places per the research SOP. Assures that amended consent forms are appropriately implemented and signed respectively.
- Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility accurately.
- Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Coordinates patient visits as assigned by research manager.
- Registers each participant in the electronic data capture (EDC) to ensure billing of study procedures to the appropriate funding source.
- Collects data as required by the protocol.
- Assures timely completion of Case Report Forms, paper or electronic. Must be attentive to data queries and resolve them within the required timeframe.
- Works with other members of the study team and clinical team to recruit eligible candidates to meet enrollment goals.
- As delegated by research manager, collects documents needed to initiate the study for sponsor submission (e.g., FDA Forms 1572, CVs, medical licenses, IRB applications, etc.).
- Maintains adequate inventory of study supplies. If handling investigative drugs/devices, follows the sponsor protocol on Investigative Drug/Device Accountability.
- Documents date of training and signatures of study staff on study specific training log.
- Creates source documents for data capture per study protocol and manual of procedures.
- Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.
- Coordinates monitor site visits and assists with preparation of site visit documentation.
- Maintains CVs and training materials per protocol.
- Assist patients with insurance coverage of medication if not covered by sponsor.
- Attends teleconferences and Investigator Meetings as requested by research director.
- High School Diploma or GED
- Previous experience in clinical research
- Highly motivated and self sufficient
- Ophthalmology experience