Clinical Research Coordinator

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.