Clin/Tran Research Coord 3

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Organization:

Pediatric Infectious Disease

Job Summary:

JOB SUMMARY

This position is with the Halasa/Chappell Lab, jointly led by Drs Natasha Halasa and Jim Chappell, within the Division of Pediatric Infectious Diseases at Vanderbilt University Medical Center. Our laboratory research concentrates on the etiology, epidemiology, prevention, and pathobiology of infectious diseases.

This position will perform a variety of duties involved in the collection, interpretation, and documentation of data in support of clinical trials. Assists in ensuring adherence to protocols, appropriate regulations, and deadlines. Ensures quality of information received.

The individual in this position will be responsible for planning through completion and reporting, assuring that the processes, integrity and quality of the research are assessed and maintained and that the studies are conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols. This role will also serve as a resource for inquiries and maintains communication with the investigators, participants, sponsors, IRBs, DSMBs and other research related entities.

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REQUIREMENTS FOR SUCCESS

• Advanced knowledge and understanding of policies, procedures, and regulations governing human subject's research, and stipulations of sponsor contracts or requirements and incorporates them in the conduct of research.

• Advanced knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations

• Advanced knowledge of the policies and procedures and requirements of Vanderbilt departments involved in the approval of research (IRB, grants, contracts, finance, etc.) and the ability to proficiently and compliantly maneuver though the approval processes and then assure compliance throughout the research process

• Advanced knowledge and understanding of the management and implementation of clinical/translational research operations
   

KEY RESPONSIBILITIES

Clinical Research Compliance

• Compliantly, accurately and proficiently prepares, processes and manages new research proposals, amendments, continuing review applications, adverse event reports, and budgets

• Performs or instructs others in performing procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and reporting as required by policy, regulations or protocol, to the sponsor and regulatory agencies

• Accurately and compliantly prepares and maintains documents required to be maintained internally and available for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures. Participates in data quality assurance reviews

Clinical Research Project Coordination

• Understands, implements, and follows a clinical/translational study protocol and is able to conduct multiple studies independently, obtaining training or training others to safely and accurately perform or assess required protocol procedures

• Participates in the determination of eligibility and recruits candidates for study participation. Troubleshoots trial recruitment strategies to ensure trials are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation

• Works collaboratively with other staff and depart