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Psychiatrist – Principal Investigator, Clinical Research
Hawthorne Health. Accurately document findings and contribute to ongoing clinical trials, registries, or research protocols as applicable .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trials, ensuring compliance with ICH-GCP guidelines and FDA regulations, while effectively leading a clinical research team. Possesses strong clinical judgment and communication skills to oversee patient care and maintain ethical standards in research.
Highest-signal resume keywords
Psychiatrist (MD/DO)Current, Unrestricted Medical LicenseBoard Certified or Board Eligible (BC/BE) in PsychiatryIn-Depth Knowledge of ICH-GCP GuidelinesProven Leadership and Team Management Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Trial ManagementPatient Assessment ReviewLaboratory Result InterpretationMedical Decision-MakingData Collection and Documentation
Soft Skills
Strong Verbal and Written Communication SkillsExceptional Organizational SkillsMeticulous Attention to DetailAbility to Prioritize Tasks Effectively
Tools & Technologies
Good Clinical Practice (GCP)FDA RegulationsClinical Research Protocols
Certifications & Qualifications
Board Certified or Board Eligible (BC/BE) in Psychiatry
Industry Keywords
Clinical TrialsContract Research Organizations (CROs)Institutional Review Boards (IRBs)Investigational Product AccountabilityEthical Conduct
About the role
Key responsibilities & impact- Accurately document findings and contribute to ongoing clinical trials, registries, or research protocols as applicable
- Oversee and manage all aspects of clinical trials conducted at the research site
- Ensure adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements
- Lead and supervise the clinical research team, including sub-investigators, study coordinators, and other site staff
- Delegate study-related duties to qualified personnel and ensure proper training and oversight
- Conduct remote review of patient assessments, physical exams, medical histories, and eligibility screenings
- Review and interpret laboratory results, ECGs, and other diagnostic tests
- Make medical decisions regarding participant care, adverse events, and protocol deviations
- Ensure accurate, complete, and timely collection and documentation of study data
- Communicate with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities
- Manage investigational product accountability, storage, and administration according to protocol with the on-site IP team
- Participate in site initiation visits, monitoring visits, audits, and inspections
- Maintain continuous medical education and stay current with clinical research and relevant therapeutic areas
Requirements
What you’ll need- Psychiatrist (MD/DO)
- Current, unrestricted medical license
- Board Certified or Board Eligible (BC/BE) in Psychiatry
- Demonstrated in-depth knowledge of ICH-GCP guidelines, FDA regulations, and other relevant ethical and regulatory requirements for clinical research
- Proven leadership and team management skills
- Excellent clinical judgment and decision-making abilities
- Strong verbal and written communication skills in English, with the ability to present complex information clearly and concisely
- Exceptional organizational skills and meticulous attention to detail
- Ability to manage multiple complex studies simultaneously and prioritize tasks effectively
- Commitment to ethical conduct and patient safety
- Experience leading at least three sponsor initiated trials as a PI or Sub-I, highly preferred
Benefits
Comp & perks- Part-time, 1099 independent contractor opportunity
- Opportunity to supplement an existing clinical practice
- Contribute to research designed to expand patient access to innovative treatment options
- Additional oversight responsibilities performed remotely