Responsibilities

• Act as the primary point of contact for all trial-specific medical and safety-related inquiries from all stakeholders.
• Provide expert medical input for responses to regulatory authorities and Institutional Review Boards (IRBs) regarding trial-specific medical and safety questions.
• Continuously monitor the safety of trial participants and ensure the highest standards of patient care.
• Engage in activities aimed at boosting trial participant recruitment and enhancing retention.
• Deliver presentations on medical matters during kick-off and investigator meetings.
• Train the trial team on therapeutic areas and the medical components of study protocols.
• Develop and review trial-specific documents to ensure compliance with medical monitoring standards.
• Identify and manage ongoing trial risks associated with medical and safety issues.

Requirements

• US Board Certification in Gastroenterology.
• Extensive experience in clinical trials and medical monitoring.
• Strong understanding of regulatory guidelines and ethical standards related to clinical research.
• Excellent communication skills, both verbal and written, with the ability to present complex medical information clearly.
• Demonstrated ability to work collaboratively in a team environment.
• Proficient in developing training materials and conducting training sessions for clinical trial teams.
• Detail-oriented with strong organizational and time management skills.

Benefits

• Competitive salary and benefits package.
• Flexible work environment with the option to work from home.
• Opportunity to work with a leading Contract Research Organization.
• Access to professional development and training opportunities.
• Be a part of a dynamic team that prioritizes patient safety and quality service.
• Engage in innovative projects within the healthcare and clinical research sectors.