Clin/Trans Research Coord I (CTRC I) - Onsite, Nashville TN

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:

Neurology Admin 20

Job Summary:

The Behavioral and Cognitive Neurology division is a multidisciplinary research team comprised of professionals dedicated to improving the lives of those with neurodegenerative disorders and their families. The mission of our division is to develop and improve individualized care for those living with neurodegenerative diseases. The division accomplishes this through research that focuses on assessing therapeutic outcomes, understanding brain-behavior relationships through use of innovative neuroimaging techniques, identifying biomarkers for treatment development, and assessing stress and coping in multigenerational families affected by genetic neurological conditions, including adults, adolescents, and children as young as 6 years old. Excellent patient care and devotion to the mission are the highest priorities of the division.

Behavioral and Cognitive Neurology is seeking a Clinical Translational Research Coordinator I to join the team to coordinate multiple studies across the division. This pivotal role is responsible for aspects of running clinical research studies, including preparing and submitting IRB applications, accurately maintaining documents during and after the study, participating in determination of eligible candidates for study participation, scheduling and running participant visits, shipping specimens, and more. A bachelor’s degree is required in a related field.

Preferred Experience:
Familiarity with study start up and close out
2+ years of clinical trial experience
Patient recruitment experience
Date collection and management experience

NOTE: This is a FULLY ON-SITE, patient-facing position that will require occasional evening and weekend work. Prior experience working with children is strongly preferred.

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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