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Location: Remote
Website
Lotus Clinical Research | Global CRO for CNS, Pain, Obesity & Metabolic Trials with Integrated Site Network [https://lotuscr.com/]
About this role
Primary responsibilities include medical and safety oversight of clinical trials. The Contract Medical Monitor, Psychiatrist provides services to clinical trials with the aim to monitor the safety and wellbeing of study participants, integrity of the project data in accordance with the clinical trial protocol/clinical study protocol (or equivalent documents), standard operating procedures (SOPs), good clinical practice (GCP), and all other applicable directives and regulatory requirements.
This role will be up to 20 hours per week with potential to increase after Q1 2026. This project is long-term.
Responsibilities
- Other duties may be assigned. Employee performs all, part, and/or any combination of the duties listed below.
- 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 for 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, event seriousness, expectedness, causality and identify potential safety signals at single case level. 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 (EOS) assessments
- Provide review of adverse events, concomitant medications and medical history to assess overall risks to subject safety in addition to coding of these data according to relevant dictionaries (MedRA/WhoDrug)
- 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 (CSR) regarding overall study conduct, protocol deviations, representation of adverse events and other safety data, and general conclusions regarding safety and tolerability and assessment of the objectives.
Qualifications
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- 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
Experience
Excellent organizational and advanced reasoning skills. Strong written and verbal communication skills. Exceptional attention to detail. Strong interpersonal skills. Strong computer skills, including ability to effectively utilize common Microsoft Office products such as Outlook, MS Word and Excel.
