Clinical Research Coordinator 1 (Internal Medicine)

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:

Internal Medicine

Job Summary:

Responsible for coordinating the approval processes and conduct of research protocols, such that the integrity and quality of the clinical/translational research is maintained and the research is conducted in accordance within all policies, with some guidance.

Department Summary:

The Division of General Internal Medicine and Public Health within the Department of Medicine at Vanderbilt University Medical Center is committed to providing excellent care for patients and improving community health.

Nearly 400 faculty members and advanced practice providers within 10 sections care for a large patient base, play an essential role in the training of new physicians, and contribute to a robust research portfolio. 

Throughout the pandemic and beyond, our faculty have remained resilient and focused on advancing knowledge, training the next generation of health care leaders, and caring for the patients and families who entrust Vanderbilt with their care.

The Division of General Internal Medicine and Public Health has seen remarkable growth over the past decade. Meeting the demands of the growing Nashville community, the division has led a massive expansion in primary care services.

Together, our team reached nearly 370,000 outpatient and 14,000 telehealth visits last year.

Our care does not stop in the outpatient arena. Hospital medicine is a rapidly growing section, accounting for the vast majority of nearly 80,000 inpatient encounters.

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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 t