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Contract Medical Monitor, Psychiatrist
Evolution Research GroupContract Medical Monitor overseeing medical and safety for clinical trials at Lotus Clinical Research. Responsible for ensuring participant safety and data integrity according to regulatory requirements.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Primary responsibilities include medical and safety oversight of clinical trials
- Provides services to clinical trials with the aim to monitor the safety and wellbeing of study participants
- Ensure integrity of the project data in accordance with clinical trial protocols, SOPs, GCP, and regulatory requirements
- Perform in-depth medical assessment of key study information through review of the protocol, Investigator Brochure, Informed Consent Form, and appropriate literature
- Provide medical input for protocol design, as appropriate
- Participate in Site Initiation Visits and/or Investigator Meetings
- Provide 24/7 medical consultancy support to investigators and study team
- Prepare and/or review the Medical Monitoring Plan, as well as the Safety Management Plan and related study documents
- Support the clinical team for subject selection regarding interpretation and application of the protocol inclusion and exclusion criteria
- Follow study status via email, phone calls, and participation in team meetings
- Participate in safety review meetings per protocol
- Perform review of Serious Adverse Events (SAE) reported by sites to assess medical contents and case completeness
- Collaborate with site staff, Lotus team members and sponsor staff to finalize each event
- Develop and/or SAE narratives and MedWatch reports
- Review protocol deviations and classify according to agreed criteria
- Provide support for the clinical team regarding early discontinuation of treatment and end of study assessments
- Provide review of adverse events, concomitant medications and medical history to assess overall risks to subject safety
- Provide Medical review of other study data such as laboratory results, ECGs, etc. per the scope of work
- Provide review and comment on the Clinical Study Report regarding overall study conduct and safety data
Requirements
What you’ll need- 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
Comp & perks- Flexible work hours
- Remote work options
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
medical assessmentclinical trial protocolsSOPsGCPSAE narrativesMedWatch reportsadverse event reviewclinical study report reviewprotocol designsafety management plan
Soft Skills
communication skillsteam collaborationfast-paced environment adaptabilitymedical consultancy supportproblem-solvingattention to detailinterpersonal skillsorganizational skillsleadershipcritical thinking
Certifications
medical degreeactive medical license