Job Description
About Denali Health
Denali Health is a growing, multi‑therapeutic clinical research site network dedicated to accelerating the development of life‑changing treatments. Our Plant City campus features state‑of‑the‑art research facilities, a robust patient database, and a passionate team focused on quality data, rapid enrollment, and inclusive participant care.
Role Summary
We are seeking a Psychiatry Sub‑Investigator to support our Principal Investigators across multiple Phase II‑IV psychiatric studies. The ideal candidate is a Florida‑licensed psychiatrist with hands‑on experience in at least three (3) interventional clinical trials and a commitment to Good Clinical Practice (GCP). You will conduct study‑related assessments, ensure protocol compliance, and collaborate with cross‑functional teams to keep trials on time and audit‑ready.
Core Responsibilities
- Clinical Oversight:
- Perform diagnostic and safety assessments (e.g., HAM‑D, MADRS, PANSS, C‑SSRS) per protocol.
- Evaluate and document adverse events, concomitant medications, and protocol deviations.
- Regulatory & Quality:
- Adhere to ICH‑GCP, FDA, and IRB requirements; assist with regulatory submissions as needed.
- Participate in sponsor/CRO monitoring visits and address data queries promptly.
- Patient Engagement:
- Obtain informed consent alongside the study team.
- Maintain positive rapport with participants to support retention and data integrity.
- Collaboration:
- Work closely with CRCs, raters, and data managers to meet enrollment & data‑lock milestones.
- Attend site qualification, initiation, and close‑out visits; provide medical leadership when PI is unavailable.
Minimum Qualifications
RequirementDetailsLicensureActive, unrestricted MD/DO license in Florida (or eligibility to obtain before start date).TrainingBoard‑eligible or board‑certified in Psychiatry.Trial ExperienceDocumented participation in ≥ 3 interventional psychiatric clinical trials as Sub‑I or PI.GCP KnowledgeFormal GCP training within the last 2 years; familiarity with eSource/eReg & EDC systems.SkillsExcellent clinical judgment, precise documentation, strong communication with sponsors & CROs.
Preferred Extras
- Prior work in inpatient psychiatry, substance‑use disorder, or neuro‑degenerative studies.
- Experience with decentralized trial tools (ePRO, tele‑visits).
- DEA certification & familiarity with Schedule II medication management.
What We Offer
- Competitive per‑study stipend and performance bonuses.
- Flexible scheduling that can accommodate private practice or academic commitments.
- On‑site rater certification and protocol‑specific training.
- Access to Denali Health’s professional development resources and nationwide investigator network.
Denali Health is an equal‑opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees and research participants.