Clinical Research Coordinator II (Sleep Tech)
About the Role
Join a high-impact sleep research team and play a central role in bringing cutting-edge clinical/translational studies to life. In this position, you’ll coordinate study start-up and day-to-day execution of both industry and federally-funded sponsored sleep research—ensuring excellent data quality, participant safety, and full compliance with IRB and regulatory requirements. You’ll also have the opportunity to work closely with Dr. David Kent, advancing research that helps shape the future of sleep medicine.
Responsibilities
- Coordinate the approval processes and conduct of sleep research protocols from start-up through close-out.
- Manage IRB/regulatory activities (submissions, amendments, continuing review, documentation).
- Conduct 1–2 overnight sleep studies a week (varies with scheduling and research participants, allowing for a flexible schedule).
- Ensure protocol adherence, accurate documentation, and high-quality data collection.
- Partner with investigators, clinical staff, and research support teams to keep studies running smoothly and on timeline.
- Proficiently prepare and process new IRB research proposals, amendments, continuing review applications, and adverse event reports according to institutional, departmental, and federal regulations.
- Accurately and compliantly prepare and maintain documents required for regulatory authorities and/or the sponsor before, during, and after clinical/translational trials.
- Participate in periodic site visits from sponsors, regulatory authorities, and others to review research, source documentation, and research procedures.
- Identify and procure equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required).
- Participate in determining eligible candidates for study participation, ensuring participants fulfill eligibility requirements.
- Strive to ensure studies are completed in a timely manner through effective screening, recruitment strategies, and required documentation.
- Assess and evaluate potential participants' pertinent medical and historical information to ensure only appropriate subjects are enrolled and remain eligible.
- Record data from source documentation and/or participant interaction onto case report forms (paper or electronic) with attention to accuracy, completeness, and timeliness.
- Attend to query resolution promptly.
- Ensure research information is collected and stored in compliance with regulations, policies, and good clinical practice.
- Perform packaging and shipping of study specimens (blood, urine, etc.) to sponsors or laboratories in accordance with guidelines and regulations, maintaining appropriate documentation.
- With direction, develop and manage study budgets, monitor efficient invoicing, and maintain clinical trial billing compliance, providing reports to investigators, department administration, and funding agencies.
- Serve as an advocate for human subjects by establishing and maintaining communication with investigators, research staff, sponsors, participants, and professional organizations.
- Participate in the ongoing informed consent process, ensuring participants, their families, and healthcare providers understand expectations.
- Participate in research-related programs, such as the Clinical/Translational Research Staff Council, by submitting issues, suggesting solutions, and sharing information with other research personnel.
Requirements
- Bachelor’s degree (or equivalent experience).
- 1 year of clinical research experience preferred.
- RPSGT (Registered Polysomnographic Technologist) certification - required.
- Experience with Epic or other EHR.
Skills
- Clinical Research (Novice): Can research problems spanning several areas of the department. Develops and writes basic trial protocols. Designs data collection forms. Has developed networking skills to assist in researching issues.
- Study Design & Conduct (Novice): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasks within the life cycle of a study.
- Project Coordination (Novice): Reviews project-related documents for completeness and accuracy. Provides administrative and logistics support for project meetings, training, and workshops. Coordinates and tracks work requests to ensure on-time project delivery.
- Communication (Novice): Clearly, effectively, and respectfully communicates with employees or customers.
Benefits
- Monday–Friday schedule with flexibility.
- Meaningful, hands-on work that directly supports research participants and scientific progress.
- Close collaboration with a leading investigator in sleep research.
- A role blending clinical skill, coordination, and regulatory rigor—excellent for long-term growth in clinical research.
Work Locations
Training: Vanderbilt Medical Center East — 1211 21st Ave S, Nashville, TN
After training: One Hundred Oaks — 719 Thompson Ln, Nashville, TN
Department Summary
The specialists at Vanderbilt Otolaryngology–Head & Neck Surgery are worldwide leaders in research. As pioneers in the otolaryngology field, our discoveries significantly impact science and change surgical and treatment options available to patients. Vanderbilt Otolaryngology-Head & Neck Surgery typically ranks between second and third in the nation for NIH grant funding. Our programs focus on academics, science, and patient care that translate into top-tier research and clinical trial options for our patients.
For additional information, please visit VUMC Otolaryngology Research and Clinical Trials.