Clinical Research Manager

Manage and oversee FDA-regulated clinical trials, including supervision of clinical research staff and execution of protocol-driven clinical research activities. The role requires independent judgment to apply clinical knowledge to research protocols, adhere to clinical research methodology, and ensure compliance with FDA regulations, ICH-GCP guidelines, and ALCOA+ data integrity standards. The position supports clinical trials involving circadian-based testing and therefore requires flexibility to work non-standard hours, including evenings, overnight shifts, and weekends. The Clinical Research Manager operates with minimal supervision and is responsible for maintaining regulatory compliance, research quality, and operational integrity across multiple clinical studies. Duties include:

1. Independently manage multiple Phase II–IV clinical trials in sleep medicine, from study initiation through close-out, prioritizing research activities to guide research assistants and technicians.

2. Perform advanced protocol-required clinical procedures, including phlebotomy and biological sample handling, in compliance with GCP and safety standard; coordinate participant visits and laboratory procedures (ECG, blood draw, urine, tissue samples, etc.).

3. Conduct and oversee neurophysiology studies (e.g., electrocardiogram, polysomnogram, maintenance of wakefulness test, multiple sleep latency test) and other specialized sleep-related research assessments requiring overnight, early-morning, late-evening, and weekend office hours.

4. Exercise professional judgment in complex visit scheduling and protocol execution aligned with circadian and pharmacokinetic study designs.

5. Collect and review patient medical and surgical histories, laboratory and procedure test results, concomitant medications, and adverse events.

6. Reviewing patient conditions and symptoms to facilitate communication between patients and healthcare providers.

7. Respond to participant emergencies as needed at any time of the day 24/7, applying an understanding of medical relevance of adverse events to address immediately with healthcare providers.

8. Provide direct managerial supervision of research assistants and sleep technicians, including training, workflow oversight, performance evaluation, and quality control.

9. Ensure full compliance with FDA regulations, ICH-GCP, ALCOA+ data integrity principles, and sponsor-specific requirements.

10. Review, approve, and ensure accuracy of source documentation, EDC data, and regulatory files prior to sponsor monitoring and audits.

11. Oversee investigational product accountability, including receipt, storage, temperature monitoring, reconciliation, and documentation.

12. Serve as senior operational liaison with sponsors, CROs, monitors, and auditors, independently addressing findings and implementing corrective and preventive actions.

13. Develop and execute SOPs and provide subsequent education to all workers.

14. Apply ethics principles governing clinical research involving human subjects and ensure ethical conduct of research through proper informed consent processes and continuous subject safety monitoring.

15. Contribute to research program development, protocol feasibility assessments, and operational optimization within the clinic.

16. Ensure all personnel are appropriately delegated to their research tasks with proper training and documentation as well as maintaining delegation log.

17. Processing laboratory samples including centrifuging, separating samples, and ensuring proper storage and transport as well as obtaining any research materials not provided.

18. Supporting participant safety, protocol compliance, and data accuracy.

Position requires (1) Bachelor’s degree in Medical Studies, Clinical Laboratory Science, or closely-related medical field, to include coursework in patient care, clinical medicine, human physiology, and pathology/disease. (2) 12 months of experience in a clinical research position, to include: (a) Independently coordinating multiple clinical studies and prioritizing research activities to guide research assistants and technicians. (b) Adhering to clinical research methodology and ensuring regulatory compliance. (c) Collecting and reviewing patient medical and surgical histories, laboratory and procedure test results, concomitant medications, and adverse events. (d) Reviewing patient conditions and symptoms to facilitate communication between patients and healthcare providers. (e) Coordinating participant visits and laboratory procedures (ECG, blood draw, urine, tissue samples, etc.). (f) Processing laboratory samples including centrifuging, separating samples, and ensuring proper storage and transport. (g) Applying ethics principles governing clinical research involving human participants. (h) Applying clinical knowledge to research protocols. (i) Understanding medical relevance of adverse events to address immediately with healthcare providers. (j) Supporting participant safety, protocol compliance, and data accuracy. (3) Certification of training in Human Subjects Protection (HSP), Good Clinical Practice (GCP), and Transporting Dangerous Goods relating to clinical laboratories. (4) Occasional national travel 1-3 times per year to attend investigator meetings, sponsor-required study meetings, national meetings, and clinical research coordination activities related to FDA-regulated clinical trials in sleep medicine. (5) Work schedule normally Monday-Friday 8:30am to 5pm. Employee must have flexibility to work occasional early, late, or weekend hours 2-3 times per month to perform assessments of sleep-related research and respond to patient emergencies. In addition, this position is on call 24/7 to address any emergencies from home on weekends and overnight. (6) This position oversees 4-6 research assistants and 2-3 sleep technicians.