Job Description

Responsibilities:

• Coordinate and participate in site initiation and other sponsor-required training for all protocols.
• 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.
• 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.
• Create source documentation forms/templates to ensure accurate collection of all study data; maintain research subject charts/binders to meet protocol requirements.
• 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 internal Health policy.
• 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 internally.
• 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.
• Determine effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Actively recruit, screen and enroll participants in trials.
• Attend investigator/coordinator meetings as required by study sponsors.
• Serve as liaison between participants, physician investigators, sponsors of research, IRBs, research institute administration, patient care coordinators and insurance companies to assist in protocol interpretation, clinical and safety questions, and pre-authorization questions.
• 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.

Qualifications:

• Minimum 3 years of experience conducting clinical trials required; worked as primary research coordinator for at least 5 drug or device trials.
• Minimum 3 years of experience interacting with patients in a healthcare setting required.
• Thorough knowledge and understanding of research regulatory requirements involving human subjects research, including FDA, OHRP and GCP requirements required.
• Experience in implementation of research protocols and clinical trials processes required.
• Experience in preparing and maintaining regulatory documents and other IRB-related study documentation required.
• Experience using electronic data capture software required; Clinical Trial Management Systems (CTMS) preferred.
• Lab processing experience required, Phlebotomy certification preferred.
• Bachelor’s degree in a science or health-related field or a combination of education and/or additional job-related experience in lieu of the degree, required.

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