Clinical Research Coordinator 1 - VCC - VICTR

Discover Vanderbilt University Medical Center:  Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt’s mission is to advance health and wellness through preeminent programs in patient care, education, and research.

Organization:

VICTR

Job Summary:

JOB SUMMARY
In your pivotal role as a Clinical Research Coordinator 1, 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.

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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KEY RESPONSIBILITIES

• With assistance, 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
• Prepares and maintains documents required to be maintained and available internally and 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 Procures equipment and supplies needed to fulfill project requirements
• 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
• 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
• With direction assists with study completion, study closeout and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports
• With supervision, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance
• 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
• Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements.
• With guidance, assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation.
• Engages in open and positive communication with study participants and coworkers With direction, performs or instructs others in performing procedures for research as they are described in the protocol, deviating from the protoc