Clinical Research Coordinator I - 100% On Site

Discover Vanderbilt Health : With eight hospitals and over 180 clinics, we are the region’s largest comprehensive academic health system. Vanderbilt Health has a long tradition of providing world-class care to the people of the Mid-South, living out our mission of moving medicine forward through preeminent programs in patient care, education and research. Here you’ll find a spirit of collaboration and a supportive community where your expertise is valued, your knowledge expanded and your uniqueness celebrated. We are committed to fostering an environment where talented, compassionate people are united in bringing the most advanced care to our neighbors throughout the region.

Organization:
Neurology Admin 20

Job Summary:
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. This division focuses on diagnosis, treatment and scientific study of neurodegeneration, with a focus on cognitive, movement, and behavioral disorders. Our team integrates clinical neurology, neuropsychology, neuroscience, neuroimaging, and translational research to advance clinical care and treatment options for our patients and their families.

The Behavioral and Cognitive Neurology division is seeking a highly motivated Clinical Translational Research Coordinator I (CTRC 1) to join the team. The coordinator will be responsible for 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 with all policies. The CTRC 1 will work closely with investigators, clinicians, patients, caregivers, and other team members to support the execution of pharmaceutical-sponsored clinical trials, foundation funded observational studies, and NIH funded research.

The Darby Lab uses a combination of structural MRI, functional connectivity MRI, and behavioral testing to understand complex neurological disorders involving cognitive impairment, psychosis, and/or abnormal social behavior. The applicant will be primarily responsible for coordinating clinical research studies in patients with frontotemporal Lobar Degeneration (FTLD), as well as Alzheimer’s disease and Parkinson disease. The Darby Lab displays a wide range of research studies from longitudinal natural history studies, studies on social decision-making, and clinical trials that range from phase 1-3, including gene therapies.

The division is committed to training the next generation of clinicians, scientists, and research professionals. The division provides extensive education and professional development opportunities for research coordinators, neurology residents and fellows, graduate students, postdoctoral trainees, and students exploring careers in neuroscience, medicine, neuropsychology, nursing, and more. Team members participate in a variety of experiences including weekly meetings, seminars, protocol trainings, journal clubs, observe clinical evaluations, non-invasive procedures, neuroimaging, and cognitive assessments, and have opportunities to obtain hands-on experience and training in good clinical practice (GCP), human subjects protections, regulatory processes, biospecimen handling, cognitive testing, clinical data collection, and others. Additionally, there are mentorship opportunities from faculty, research managers, and other staff.

This is an excellent opportunity for candidates interested in neurology, neuropsychology, neuroscience, or medicine who want hands-on clinical research experience in a collaborative academic environment. Skills in organization, problem solving, effective communication, and motivation are highly desired. Strong interpersonal skills in empathy and comfort working with individuals with cognitive and movement symptoms is required. This is a fully in-person job with potential occasional evening or weekend hours.

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BEHAVIORAL & COGNITIVE NEUROLOGY MISSION AND VALUES STATEMENTS

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Mission Statement

To improve the lives of patients with cognitive and behavioral disorders, their families, and society through innovative clinical care, research, education, and community engagement.

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Values Statement

To achieve this mission, we will develop and maintain a culture that values personal autonomy, collaboration, and innovation. We will empower those within the division to develop expertise, compassion for patients, respect for others, and passion for their work.

KEY RESPONSIBILITIES (Novice)

• Understanding and capability to accurately and compliantly perform the procedures required of each study protocol, working collaboratively with study participants, other staff and departments, in safely and accurately performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, administering neuropsychological assessments, conducting interviews regarding mental health and quality of life, tracking medication usage, etc.

• Basic knowledge and understanding of the implementation, coordination, management and reporting of clinical/translational research operations.

• Ability to identify and troubleshoot problems.

• Records data from 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 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.

• Engages in open communication with participants by providing them with contact information and being available to answer, address or refer their calls.

• Demonstrates knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in the conduct of research.

• Demonstrates 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.

• 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/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation, and research procedures.

• Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation.

• Knowledgeable of the safety reporting requirements of the study protocol, IRB, 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 the public responsible for, or concerned abou