Clinical Research Coordinator

Duties:

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 required time frame

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 required time frame

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 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 the sponsor

Obtain any applicable additional/required sponsor training and/or certifications