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.