JOB SUMMARY:

The Clinical Research Coordinator obtains human subject data for clinical research activities via methods specified in the study protocol and performs general administrative duties supporting the study.

ESSENTIAL JOB FUNCTIONS:

• Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other regulatory activities.
• Schedules, coordinates, and participates in the pre-site visit and site initiation visits; coordinates study initiation.
• Maintains and monitors source documentation and appropriate forms as per protocol for quality and accuracy, including participant records; assists with the quality assurance process.
• Incorporates directions from other health care disciplines into clinical research protocols when reviewing patient eligibility; assists in eliciting relevant data from sources outside of the hospital.
• Reconciles study drug accountability; maintains temperature and QC logs per protocol compliance.
• Develops and maintains productive working relationship with the study monitor; attends and participates in campus coordinator workshops.
• Identifies and recruits clinical research subjects for participation of studies, collects data, and monitors enrollment goals.
• Mentors new clinical research coordinators and assistant clinical research coordinators.
• Assists with grant/protocol preparation and submission to IRB, OCR or OSP under direction of research coordinator under the direction of the PI and with answering IRB stipulations to obtain final approval; documents IRB approval and contract approval.
• Under direction of PI may draft various communications with Sponsor and/or regulatory documents to be sent to the Sponsor.
• May assist PI and/or research nurse coordinator in the planning and design of source documents for protocol.
• Assists in developing procedures for laboratory collection and storage.
• Assists in processing and shipping lab specimens; retrieves and/or sends identified research specimens certified if indicated as per regulations.
• Assists in precepting new clinical research staff and educating other research staff regarding scientific aspects of studies.
• Assists in processing and shipping lab specimens efficiently and cost effectively; maintains supply inventory and equipment; maintains regulatory standards.
• Assists with the budget development; may monitor ledgers.
• Adheres to internal controls established for department.
• May assist PI in obtaining Informed Consent from study participant and documents appropriately.
• Adheres to internal controls and reporting structure.

MARGINAL OR PERIODIC JOB FUNCTIONS:

• If appropriately trained and tested for competency, obtains Vital Signs and performs phlebotomy; monitors participants’ labs and notifies the PI of laboratory findings.
• May attend and participate in the Investigator meeting
• Performs related duties as required.

REQUIRED EDUCATION / EXPERIENCE:

Bachelor’s degree or equivalent, and two years of directly related experience.

EQUIPMENT:

Standard office equipment.

WORKING ENVIRONMENT/LOCATION OF POSITION:

Standard hospital, clinical, laboratory and/or office environments.