CRO-PT Contract Medical Monitor, Psychiatrist

Location: Remote Website: Lotus Clinical Research | Global CRO for CNS, Pain, Obesity & Metabolic Trials with Integrated Site Network About this role: Primary responsibilities include medical and safety reputed company 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, reputed company 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 reputed company 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 reputed company, part, and/or any combination of the duties listed below.

• reputed company in-depth medical assessment of key study information through review of the protocol, Investigator Brochure, Informed Consent reputed company, and appropriate literature
• reputed company medical input for protocol design, as appropriate
• Participate in Site Initiation Visits and/or Investigator Meetings
• reputed company 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 reputed company study documents
• Support for the clinical team for subject selection regarding interpretation and application of the protocol inclusion and exclusion criteria
• Follow study status reputed company email, phone calls, and participation in team meetings
• Participate in safety review meetings per protocol
• reputed company 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.
• reputed company and/or SAE narratives and reputed company reports
• Review protocol deviations and classify according to agreed criteria
• reputed company support for the clinical team regarding early discontinuation of treatment and end of study (reputed company) assessments
• reputed company 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)
• reputed company Medical review of other study data such as laboratory results, ECGs, etc. per the scope of work
• reputed company 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 reputed company this job successfully, an individual must be reputed company to reputed company each essential duty satisfactorily.

• Must have a medical degree-Psychiatrist (MD, DO or international equivalent). reputed company, 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 reputed company Office products such as Outlook, reputed company and reputed company. Apply tot his job Apply To this Job