Medical Monitor (US Board-Certified Gastroenterologist)

Responsibilities

• Acts as the primary point of contact for all parties on all trial-specific medical and safety-related questions
• Provides input for responses to regulatory authorities and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs) on trial-specific medical and safety-related questions
• Makes sure trial participants stay safe
• Helps find and keep people interested in participating in the study
• Talks about medical stuff at the start and during meetings with doctors
• Teaches the team about the medicine being studied and its effects
• Checks and makes sure trial documents are correct
• Looks out for problems in the study and helps fix them
• Checks the main study information regularly and helps the person checking the data
• Answers questions from sponsors about safety
• Looks at safety reports and helps write them
• Works with other groups to make sure the study runs smoothly
• Helps decide if a new study should be done
• Speaks with clients about bids and other things
• Helps other parts of the company understand medical stuff
• Prepares for and goes to study inspections
• Helps figure out if a study can work in a certain place

Qualifications

• Has a Medical Doctor degree
• Is board-certified in Gastroenterology in the US
• Has at least 10 years of experience as a practicing Gastroenterologist
• Has some experience with clinical research
• Knows how to use Microsoft Office programs
• Can talk, present, and think about problems
• Can work well in a team and pay attention to details