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