Research Coordinator (Project Management)

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.