Clinical Research Coordinator A (Department of Cardiovascular Medicine)

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Posted Job Title

Clinical Research Coordinator A (Department of Cardiovascular Medicine)

Job Profile Title

Clinical Research Coordinator A

Job Description Summary

This position requires an experienced Research Coordinator to assist in clinical research tasks in the Thalheimer Center for Cardio-Oncology. Responsibilities will include screening records for eligibility, recruitment of study subjects, conducting study visits, data collection and entry, coordinating with study team members and external departments to successfully execute studies. In addition, this position will assist with regulatory submissions.

Job Description

This position is contingent upon favorable funding.

Job Responsibilities

• Recruit patients and explain protocol and consent forms. Ensure original signed consents are maintained in study binder, Complete screening/enrollment logs and submit to sponsor, as protocol defines.
• Complete all source documents and worksheets and enter data in a timely and accurate fashion. Create and maintain subject binders. Obtain records required to complete CRFs. Ensure inclusion of enrollment information, research orders, and other communications are entered into the electronic medical record of each subject. Resolve data queries with in a timely manner.  Monitor adherence to protocol throughout patient enrollment in study. Notify PI, project manager of any deviations from protocol or adverse events. Ensure reported trial data are accurate, complete, verifiable from source documents; collect data on adverse events and reports serious adverse events per regulatory standards. Ensure correct version of approved consent is used for each enrollment. Ensure timely notification to all enrolled subjects of significant changes in consent.
• Assist in the conduct of clinical research studies performed by physicians using currently approved protocols, according to Good Clinical Practice. Obtain detailed knowledge of all components of study protocols by review of study protocol, related literature prior to study start date. Schedule and conduct follow-up visits with patients and ensure all follow-up activities are conducted within protocol designated timeframes including documentation of lost-to-follow-up efforts. Schedule additional protocol-required tests/procedures.
• Assist project manager in creating and maintaining a complete and accurate regulatory binder for each study. Assist with preparation and processing of all Institutional Review Board (IRB) documentation including submissions, continuing reviews, amendments and adverse event reporting. Prepare and process all regulatory documentation with research sponsors and clinical research organizations (CROs). Obtain the appropriate signatures for regulatory forms.  Prepare for audits and monitoring visits.