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Clinical Research Coordinator

Company: Aerotek
Location: Santa Maria
Posted on: October 10, 2019

Job Description:

Essential Duties & Responsibilities: Implement and monitor clinical trials and research projects that meet the facility/clinic objectives, and ensure compliance with protocol and sponsor requirements and all aspects of U.S. Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations, as well as institute requirements. Supports Market Clinical Research Manager (MCRM), PI, sponsors/CROs in identifying and evaluating potential new trials for feasibility of implementation at the site; provide recommendations. Complete clinical portions of sponsors' feasibility questionnaires. Prepare, manage and submit all required any required study/regulatory, documents, applications and forms, including but not limited to the applicable Institutional Review Board (IRB) application form(s), informed consent documents, 1572 forms, Conflict of Interest forms, and other forms as required by the sponsor, IRB, or the institute. Coordinate and participate in site initiation and other sponsor-required training for all protocols. Determine effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Actively recruit, screen and enroll participants in trials. To ensure protocol adherence, accurate data collection and billing compliance, instruct/advise Principal Investigator (PI) and other health care providers in the hospital/ clinic setting as to protocol-required tests and procedures to be conducted at each visit. Create source documentation forms/templates to ensure accurate collection of all study data; maintain research subject charts/binders to meet protocol requirements. Obtain PI signatures on all required study documents. Conduct informed consent process with research participants; document informed consent discussion and obtain signatures per protocol, federal, state and institutional requirements. Coordinate all study-required visits, procedures, tests and activities to meet protocol requirements; schedule participant appointments with appropriate provider/facility. Perform timely and accurate collection and reporting of data in accordance with protocol and sponsor requirements, applicable laws, and institutional policies. Dispense study medication to research participants under the direction of the PI, and/or coordinate study drug administration with hospital/clinic Pharmacy staff. Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal biologics shipping regulations. Attend local IRB and appropriate clinical department meetings, as needed, for presentation of new protocols for review. Work with billing staff to ensure clinical trials are performed in accordance with institute requirements; complete Research Encounter Forms for all participant visits. With appropriate training/credentialing, may perform blood draws, ECGs, and other testing, i.e., NIH Stroke Scale, as required by research protocols. Identify and report all unanticipated and other adverse/serious adverse events, as well as protocol deviations, violations or exceptions, to the study sponsor and IRB as required by GCP, FDA, OHRP and institute policy. Prepare for, coordinate and participate in sponsor monitoring visits or internal/external audits; resolve queries and other findings promptly; prepare responses or corrective actions plans as needed. Serve as liaison between participants, physician investigators, sponsors of research, IRBs, administration, patient care coordinators and insurance companies to assist in protocol interpretation, clinical and safety questions, and pre-authorization questions. Complete CRC activity reports accurately, and submit in a timely manner. Attend investigator/coordinator meetings as required by study sponsors. Other duties as assigned.

Keywords: Aerotek, Santa Maria , Clinical Research Coordinator, Healthcare , Santa Maria, California

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