Medical Monitor (US Board-Certified Gastroenterologist)

Remote from: USA
Annual salary: Undisclosed
Salary information is not provided for this position. Check our Salary Directory to estimate the average compensation for similar roles.
Department: Healthcare & Medical
Employment type: Full Time,
Job posted: 7 Jul 2026
Apply before: 7 Aug 2026
Experience level: Senior
Views / Applies: 130 / 7

About company

About PSI CRO

Predictable patient enrollment across multiple therapeutic areas.

Pharmaceuticals
1995

Actively Hiring

AI Summary

PSI is seeking a US Board-Certified Gastroenterologist to serve as a Medical Monitor for global clinical trials. This home-based role involves overseeing patient safety, providing medical expertise, and collaborating with cross-functional teams. The ideal candidate has at least 10 years of practicing gastroenterology and clinical research experience. Responsibilities include reviewing safety data, training trial teams, and supporting regulatory interactions. This position offers an opportunity to contribute to drug development from a medical perspective.

Role DNA

Job Complexity

Easy Hard

Pace & Pressure

Relaxed Fast-paced

Autonomy Level

Guided Full Ownership

Communication Load

Independent Highly Collaborative

AI Insight This role requires an MD, board certification in gastroenterology, and a decade of clinical practice, plus specialized knowledge in clinical research and medical monitoring. The combination of advanced credentials and experience sets a very high bar.

Salary Analysis

AI Insight No salary was provided in the listing. Based on market data for Medical Monitor roles requiring a physician and board certification, the typical US salary ranges from $200,000 to $300,000 per year, with a median around $250,000. This role's compensation is likely competitive given the specialized requirements.

Core Skills Required

Medical Monitoring Gastroenterology Clinical Research Patient Safety Regulatory Affairs Pharmacovigilance Protocol Development Data Review Team Collaboration Board Certified

Cover Letter Sample

Dear Hiring Team,

I am writing to express my strong interest in the Medical Monitor position at PSI. As a US Board-Certified Gastroenterologist with over 10 years of clinical practice and experience in clinical research, I am excited about the opportunity to contribute to your global trials. My background in patient care and trial safety aligns perfectly with the responsibilities of this role.

Throughout my career, I have developed a deep understanding of gastrointestinal disorders and have actively participated in clinical studies. I am skilled in reviewing safety data, managing protocol deviations, and collaborating with multidisciplinary teams to ensure patient well-being. I look forward to applying my medical expertise to help bring new therapies to market.

Thank you for considering my application. I am eager to discuss how my experience can support PSI's mission.

Sincerely,
[Your Name]

Sample Interview Questions

Can you describe your experience with medical monitoring in clinical trials, including how you handle safety data and protocol deviations?

In my previous role as a Medical Monitor, I was responsible for reviewing adverse events, assessing causality, and determining reportability. For protocol deviations, I evaluated their impact on subject safety and data integrity, and worked with the team to implement corrective actions.

How do you stay updated on the latest developments in gastroenterology and clinical research regulations?

I regularly attend conferences, read journals like Gastroenterology, and participate in CME activities. I also follow FDA and ICH guidelines to ensure compliance in all aspects of trial monitoring.

Describe a time when you had to communicate complex medical information to a non-medical audience, such as a study team or regulatory body. How did you ensure clarity?

I once presented a safety analysis to a sponsor team. I used simplified language, visual aids, and analogies to explain the clinical significance of the data. I also encouraged questions to confirm understanding.

How would you approach training investigators and site staff on the medical aspects of a protocol?

I would prepare a structured training module covering the disease state, study objectives, and key safety considerations. I'd use case examples and interactive Q&A sessions to reinforce learning. Follow-up materials would be provided for reference.

Can you give an example of how you managed a conflict between patient safety and operational efficiency in a trial?

In a trial where an unexpected safety signal emerged, I advocated for a temporary hold on enrollment to allow for thorough data review. Although it delayed timelines, it ensured patient safety, and we later implemented additional monitoring measures.

Company Description

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients’ safety and well-being.

Home-Based in United States

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
Monitors trial participant safety
Participates in trial participant recruitment boost and retention activities
Presents on medical matters at kick-off and investigator meetings
Trains trial team in the therapeutic area and medical aspects of the protocol
Develops and reviews trial-specific documents within the scope of medical monitoring
Manages ongoing trial risks related to medical monitoring
Performs ongoing medical review of the operational clinical trial database; provides support to Medical Reviewer(s) assigned to the trial
Reviews protocol deviations
Reviews RAE reports, writes and/or reviews SAE narratives, supports Pharmacovigilance team with outstanding safety queries, interacts with sponsor on site safety issues
Reviews IND/SUSAR Safety Reports, updates/amendments to essential trial records, and annual IND reports with sponsor data (per sponsor request)
Participates in management of trial-related committees (e.g., independent data monitoring committee (IDMC)/adjudication committees) as described in the corresponding trial-specific charter(s)
Supports Pharmacovigilance, Medical Data Review and Data Management with reconciliation of safety and operational clinical trial databases
Reviews clinical study reports (CSRs), including safety narratives and tables, figures, and listings (TFLs)
Provides medical expertise on an as-needed basis in trials where medical monitoring is not a contract deliverable
Prepares for and participates in trial audits, follows up on audit findings
Participates in feasibility assessment of potential and ongoing trials in the country/region
Participates in bid defense meetings and other interactions with clients
Acts as a medical expert and provides therapeutic expertise to other PSI departments

Qualifications

Medical Doctor degree required
US Board Certification in Gastroenterology required
Experience as a practicing Gastroenterology (minimum of 10 years)
Clinical Research experience preferred
Proficiency with MS Office applications
Communication, presentation and analytical skills
Problem-solving, team and detail-oriented

Additional Information

As part of PSI’s Medical Monitoring team, you will join our international group of medical professionals, build a career on the frontline of medical science and use your knowledge and expertise to help bring new medications to patients that need them.

Apply now >