Key Responsibilities
Participant Evaluation & Screening
- Conduct psychiatric assessments to determine eligibility for trial participation.
- Review medical and psychiatric histories to ensure compliance with study inclusion/exclusion criteria.
Ongoing Mental Health Monitoring
- Provide regular psychiatric evaluations throughout the study duration.
- Monitor for adverse psychiatric events and report findings per protocol.
Protocol Adherence
- Ensure all psychiatric procedures are conducted in accordance with the clinical trial protocol, GCP (Good Clinical Practice), and regulatory guidelines.
Documentation & Reporting
- Maintain accurate and timely documentation of assessments, findings, and interactions in the study database or EDC system.
- Collaborate with study coordinators and principal investigators to report psychiatric outcomes.
Safety Oversight
- Evaluate and manage psychiatric side effects or complications related to investigational products.
- Participate in safety review meetings and contribute to risk mitigation strategies.
Collaboration & Communication
- Work closely with multidisciplinary teams including clinical research coordinators, investigators, and sponsors.
- Provide expert psychiatric input during study design, protocol amendments, and regulatory submissions if needed.
Participant Support
- Offer psychiatric support and guidance to study participants, ensuring ethical and compassionate care.
- Refer participants for additional mental health services when necessary.
Regulatory Compliance
- Stay current with FDA, IRB, and sponsor requirements related to psychiatric oversight in clinical trials.
- Participate in audits and inspections as needed.
Requirements: Board Certified, Clinical Trial Experience, No Malpractice History, Currently Practicing
Job Type: Part-time
Pay: $100.00 - $150.00 per hour
Work Location: In person