The Clinical Research Coordinator is responsible for the coordination and administration of clinical trials under the direction and supervision of the Principal Investigator.
Carry out clinical trial activities by adhering to Good Clinical Practice and study protocols
Maintain the integrity of data while protecting the rights, safety, and well-being of patients enrolled in clinical trials
Perform phlebotomy, EKGs, and obtain vital signs
Work closely with study monitors to coordinate and carry out Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits.
Complete Feasibility Questionnaires with PI and reach out to pharmaceutical and device companies to participate in new studies
Communicate with Institutional Review Boards to maintain the proper oversight of clinical trials
Day-to-day oversight of the research team
Ensure research staff remains on task throughout the work day
Maintain a professional environment
Delegation and prioritization of tasks
Oversee recruitment of research studies in collaboration with the protocol specific CRCs and research assistants to ensure referrals are contacted within 24-hours and recruitment portals are maintained up-to-date
Manage batch shipment schedule Monday-Thursday based off of clinic and staff schedules
Work with protocol specific CRCs to ensure that binders are kept audit ready at all times
Ensure temperature controlled areas are maintained at the proper temperature and that temperature readings are documented daily upon arrival to the site
Ensure that Calibration Log is kept up-to-date
Ensure that research staff is following Research Task List in downtime
Manage the research calendar in accordance with Investigator schedules
Work with protocol specific lead CRCs to ensure that data entry and queries are attended to within a timely manner and per Clinical Trial Agreement timelines
Confirm that staff training is up-to-date at all times. Work with protocol specific CRCs to ensure that delegated staff trainings are up-to-date
Please submit cover letter to be considered for this position.