CRO-PT Contract Medical Monitor, Psychiatrist
Job Description: • Provide medical and safety oversight of clinical trials • Monitor the safety and wellbeing of study participants • Ensure integrity of project data according to protocols and SOPs • Perform in-depth medical assessment through review of relevant documents • Provide medical input for protocol design • Participate in site initiation visits and investigator meetings • Provide 24/7 medical consultancy support to investigators • Prepare and review the Medical Monitoring Plan and Safety Management Plan • Follow study status via email and participate in team meetings • Perform review of Serious Adverse Events reported by sites • Collaborate with site staff and finalize each event • Review protocol deviations and support early treatment discontinuation assessments Requirements: • Must have a medical degree-Psychiatrist (MD, DO or international equivalent) • Current, active medical license is preferred but not required • Prior clinical research experience as a medical monitor, investigator, safety physician or other applicable experience in clinical trial conduct • A minimum of 5 years of relevant experience is required • Clinical knowledge of the therapeutic patient populations and drug class • Knowledge and experience working with MedDRA and WHO Drug medical dictionaries • Broad knowledge of ICH/GCP • Excellent verbal and written communication skills • Ability to work in a fast-paced team environment Benefits: • Remote • Up to 20 hours per week • Long-term project