Medical Monitor, Dermatology, Poland or Spain

Description

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

This role will be perfect for you if:

• 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



Protocols and projects

More specifically, as required by the projects’ scope of work, the Medical Monitor will:

• 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.
• Evaluate the appropriateness of any dropout subject replacement.
• Provide emergency unblinding code-break of randomized treatment assignment.

Medical advisory role (clinical sites)

• Provides 24-hour, 7 days a week, on-call service for urgent trial-related safety issues, questions on the protocol, or other safety concerns.
• Provides first line contact for investigators, site personnel, and monitors regarding study related medical/safety issues and resolution of study protocol and subject eligibility issues.
• Provides advice to the clinical team staff / sites to answer any medical questions related to patient eligibility, and safety or clinical issues during the trial.
• Assesses the impact of any prohibited medication taken on study and evaluates any appropriate action for the subject.
• Evaluates the appropriateness of any dropout subject replacement.

Data Activities

• Provide project-related medical consultation to the Innovaderm project team members during business hours throughout the duration of the study.
• Escalate to the Project Manager or Sponsor any issues requiring medical input and significant safety or data integrity concerns identified during review of data or site contact.
• Attend meetings with Innovaderm project team members (PM, DM, stats, CRO) and/or Sponsor, as required.
• Verify the medical accuracy of subject safety data and maintain an ongoing assessment of the safety profile of the study.
• Review subject safety-related data listings/tools for the purpose of identifying potential trends, unreported protocol deviations related to safety assessments, AEs, and SAEs; and address safety concerns.
• Review protocol deviation listings to address potential safety concerns; perform impact assessment; and identify any potential trends.
• Review coding listings of adverse events, medical history, and concomitant medications to ensure all terms are coded properly.
• Assess if any stopping rule was met and evaluate any appropriate action or follow up with the subject, if applicable.
• Review clinical study report.
• Participate in the Central Monitoring activities with site data signal detection and risk management activities for the safety portion; participate in the safety review for RBM and central monitoring.

Safety Medical Monitoring and SAE Reporting Activities

• Provide medical review of SAE form, and reviews SAE causality assigned by the Investigator. 
• Write and/or review SAE narratives
• Work with the Pharmacovigi