Clin/Tran Research Coordinator - 3

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Organization:

Pediatric Endocrinology

Job Summary:

JOB SUMMARY

Under the guidance and supervision of Principal Investigators and the Research Projects Manager in the Department of Pediatric Endocrinology, the Clin/Trans Research Coordinator III is responsible for assuring that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines and Vanderbilt Policy and Procedure. The CTRC III is responsible for multiple endocrinology related trials and independently plans and implements recruitment procedures for potential participants, manages enrollment of the trial from screening to randomization to study completion, evaluates clinical data, ensures compliance with protocols and overall clinical objectives, serves as a resource for inquiries on study projects, manages study-related procedures as required by the protocol and maintains communication with the sponsor, IRB, DSMB and other research related entities.

The CTRC III should possess advanced knowledge and understanding of the planning, implementation and management of research operations.

Experience working with pediatrics and/or endocrinology related experience is strongly preferred.

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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.

• 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. Works collaboratively with other staff and departments to complete research protocols. Problem solves when needed.

• Knowledgeable of the safety reporting requirements of the study protocol, FDA and other regulatory bodies. In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies. Coordinates activities and gathers information from a variety of sources to achieve stated outcomes.

• Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants.

• Actively identifies the need for and participates in training, education, and development activities to improve own knowledge and that of the research department and to learn about and improve research related processes (i.e., research seminars, in-services, etc.). Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Actively seeks new learning opportunities, seeing continued learning as part of work. Develops and achieves personal and professional goals by engaging in a minimum of 15 hours of continu