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About this role
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