Medical Monitor (US Board-Certified Gastroenterologist)
āØ AI Insights & Summary
About PSI
PSI is a leading Contract Research Organization (CRO) with over 30 years of industry experience, offering a blend of stability and innovation. We are dedicated to delivering high-quality, on-time services across various therapeutic indications, focusing on patient safety and well-being.
The Opportunity
This is a home-based, remote Medical Monitor position within the United States. You will provide essential medical input to global clinical studies, advising teams and business partners while prioritizing patient safety. This role is integral to our Medical Monitoring team, enabling you to build a career on the forefront of medical science and help bring vital new medications to patients.
Responsibilities
- Act as the primary medical and safety contact for all trial-related inquiries.
- Provide input for responses to regulatory authorities and IRBs/IECs regarding medical and safety questions.
- Continuously monitor trial participant safety and participate in recruitment and retention activities.
- Present on medical matters at investigator and kick-off meetings, and train trial teams on protocol specifics.
- Develop and review trial-specific medical monitoring documents, managing ongoing trial risks.
- Perform ongoing medical review of the clinical trial database and support assigned Medical Reviewers.
- Review protocol deviations, RAE reports, and SAE narratives; support the Pharmacovigilance team with safety queries and interact with sponsors on site safety issues.
- Review IND/SUSAR Safety Reports, essential trial record updates, and annual IND reports.
- Participate in trial-related committees (e.g., IDMC, adjudication committees) as per charters.
- Support Pharmacovigilance, Medical Data Review, and Data Management with safety database reconciliation.
- Review clinical study reports (CSRs), including safety narratives and TFLs.
- Provide medical expertise on an as-needed basis for trials where medical monitoring is not a primary contract deliverable.
- Prepare for and participate in trial audits, managing follow-up actions.
- Participate in feasibility assessments and bid defense meetings.
- Act as a medical expert and provide therapeutic expertise to other PSI departments.
Qualifications
- Medical Doctor (MD) degree required.
- US Board Certification in Gastroenterology required.
- Minimum of 10 years of experience as a practicing Gastroenterologist.
- Clinical Research experience is preferred.
- Proficiency with MS Office applications.
- Strong communication, presentation, and analytical skills.
- Excellent problem-solving abilities, team orientation, and attention to detail.
Additional Information
Join PSI's international group of medical professionals and contribute your expertise to the development of new medications.
Apply Now
This job is active but will expire soon. Click below to apply on the company's website.
Apply for this role āShare Job
Know someone who would be a perfect fit? Share this opportunity.
Job Overview
FAQ
Is this position remote?
The Medical Monitor (US Board-Certified Gastroenterologist) role is a onsite opportunity. The location specified is USA.
What is the salary?
The salary is not explicitly stated, but is competitive and based on experience.
How do I apply?
You can apply by clicking the "Apply for this role" button above to submit your application on the hiring website.