Palo Alto, California
New Haven, Connecticut
New York, New York
Fort Harrison, IN
Durham, North Carolina
Fishkill, New York
Location: Nashville, Tennessee
Internal Number: 2116843
Clinical Research Coordinator III - VCC - VICTR
In your pivotal role as a Clinical Research Coordinator 3, you will coordinate the approval processes and conduct of research protocols, assuring that the integrity and quality of the research is maintained and that the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, VUMC policies and procedures, and research protocols.
PATIENT RECRUITMENT (ADVANCED)
Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical/translational trial. Accurately and compliantly performs the procedures required of each study 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. Reports adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations. Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation 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 the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants.
REGULATORY COMPLIANCE (ADVANCED)
Possesses knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in securing approval for and the conduct of research. Possesses knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH, and HIPAA regulations. Proficiently prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations. Possesses knowledge and understanding of the implementation, coordination, management and reporting of clinical research operations. Knowledgeable of the safety reporting requirements of the study protocol, IRB, FDA and other regulatory bodies.
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 trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures. Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness. Attends to query resolution in a timely manner. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Participates in site visits from sponsor, regulatory authorities and others to review research, source documentation, critical documents and research procedures.
CONTINUAL LEARNING (ADVANCED)
Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursues avenues to ensure awareness of the latest information available to coordinators conducting clinical/translational research (i.e., literature searchers, research seminars, in-services, etc.). Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and professional development opportunities. Engages in a minimum of 10 hours of continuous, job-related educational activities annually or pursuing an advanced career-related academic education or certification. Participates in and maintains certifications, licensure and credentialing as required by VUMC, the department and sponsor.
About the Department:
The Vanderbilt Coordinating Center (VCC) provides comprehensive, central support for a diverse platform of clinical and translational research projects. The VCC first began in 1989 under the direct leadership of Dr. Gordon Bernard. Its initial focus was on providing coordinating center support for investigator-initiated trials overseen at Vanderbilt. In 2016, with the addition of several large, innovative clinical trial grants within the Vanderbilt Institute for Clinical and Translational Research (VICTR) and due to an ever-growing need to provide more specialized, flexible support to Vanderbilt investigators, a need surfaced to reinstate the VCC. For more information, please visit https://vcc.vumc.org .
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