The Medical Monitor Dermatology provides medical and scientific support to clinical research programs. The Medical Monitor will perform thorough data review to ensure data integrity and subject safety oversight, and will communicate with sites, investigators, and internal project team members to ensure questions are promptly addressed.
Obtenga más información sobre las tareas generales relacionadas con esta ocasión a continuación, así como sobre las habilidades requeridas.
Ideal Candidate
You are skilled in building positive working relationships with all stakeholders (clinical sites, colleagues, sponsors) in a clinical research project
You skillfully balance the strict requirements of clinical research protocols with the realities of clinical trials
You are able to interpret high volumes of data and situations efficiently, and take position and advise as necessary
Responsibilities
Keep current on study protocol, study protocol amendments, Investigator’s Brochure (IB), additional safety information made available during the course of the study, and relevant clinical research guidelines involving the therapeutic indication.
Develop or review Medical Monitoring plan.
Provide project team training on study protocol and/or therapeutic area/indication.
Prepare for, attend, and present at Investigators’ Meetings.
Prepare for and attend Safety Review Meetings, as needed.
Provide 24-hour, 7 days a week, on-call (outside business hours) service for urgent safety-related matters.
Provide ongoing medical support during the study to investigators, site personnel, and monitors.
Provide advice to the sites on protocol-related issues including questions related to the protocol inclusion and exclusion criteria, concomitant medications/medical conditions, follow-up visits due and guidance on prohibited medication.
Review lab critical values and alerts.
Assess the impact of any prohibited medication taken on study and evaluate any appropriate action for the subject. xhfqzwm
Evaluate the appropriateness of any dropout subject replacement.
Provide emergency unblinding co
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