Contract Medical Monitor, Psychiatrist

Role Overview

• 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

• 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

Tech Stack

• Google Cloud Platform

Benefits

• Flexible work hours
• Remote work options