Clinical Research Coordinator II-Behavioral and Cognitive Neurology

Vanderbilt University Medical Center • Nashville, TN

6d • Onsite

About The Position

The Behavioral and Cognitive Neurology division seeks a Clinical Translational Research Coordinator II to support the approval and conduct of research protocols while maintaining research integrity and quality and complying with applicable policies. The coordinator works with investigators, clinicians, patients, caregivers, and other team members on pharmaceutical-sponsored clinical trials, foundation-funded observational studies, and NIH-funded research focused on neurodegenerative disorders.

The role includes coordinating study operations and participant activities, preparing regulatory submissions and study documentation, collecting and maintaining research data, and supporting participant safety and informed consent. The position is fully in person and may require occasional evening or weekend hours. Vanderbilt Health describes the role as an opportunity for hands-on clinical research experience in a collaborative academic environment, with access to education, training, and mentorship opportunities.

Requirements

• At least 1 year of relevant work experience is listed for the position.
• Bachelor’s degree.
• Competency in foundational skills needed to independently run clinical research studies is desired.
• Strong organization, problem-solving, effective communication, and motivation are desired.
• Strong interpersonal skills, empathy, and comfort working with individuals with cognitive and movement symptoms are required.
• Knowledge and understanding of clinical research operations and regulations governing human-subjects research, including FDA, OHRP, GCP/ICH, and HIPAA requirements.
• Ability to perform protocol procedures accurately and compliantly, maintain complete and timely study records, and communicate effectively with participants and research stakeholders.

Nice To Haves

• Experience in neurology, neuropsychology, neuroscience, or medicine.
• At least 1 year of experience and established competency in foundational clinical research skills for independently running studies.

Responsibilities

• Perform study procedures accurately and in accordance with protocols, including assessing eligibility, recruitment, scheduling, neuropsychological assessments, interviews about mental health and quality of life, and medication-use tracking.
• Coordinate, manage, and report clinical and translational research operations.
• Identify and troubleshoot problems.
• Record participant data on paper or electronic case report forms, ensuring accuracy, completeness, and timeliness, and resolve queries promptly.
• Collect and store research information in compliance with regulations, policies, and good clinical practice.
• Participate in the informed consent process and help participants, families, and healthcare providers understand the requirements of study participation.
• Maintain open communication with participants, provide contact information, and respond to, address, or refer their calls.
• Apply policies, procedures, and regulations governing human-subjects research, including FDA, OHRP, GCP/ICH, and HIPAA requirements.
• Prepare and process IRB proposals, amendments, continuing review applications, and adverse-event reports.
• Prepare and maintain required regulatory and study documents, and participate in sponsor and regulatory site visits and reviews.
• Determine participant eligibility and implement screening and recruitment strategies to support timely study completion.
• Monitor, detect, and report adverse events in accordance with protocol, IRB, FDA, and other applicable requirements.
• Coordinate activities and gather information from multiple sources to achieve study outcomes.
• Advocate for human subjects and maintain communication with investigators, research staff, sponsors, participants, participant advocates, professional organizations, and the public.
• Perform or instruct others in protocol procedures, and report protocol deviations as required when deviations are necessary for participant safety.
• Pursue training and professional development to improve knowledge and performance, and stay informed about clinical research practices.
• Participate in research-related programs and share information with research personnel.
• Attend and actively participate in weekly meetings, prepared to summarize ongoing study operations.

Benefits

• The role may include health, disability, retirement, and/or wellness offerings.
• Education, professional development, training, and mentorship opportunities are available.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level