Medical Monitor, US Board-Certified Gastroenterologist

This is a fully remote position, open to applicants in United States.

📋 Description

• Serve as the main point of contact for medical and safety-related inquiries specific to trials.

• Contribute to the preparation of responses for regulatory authorities as well as IRBs/IECs.

• Oversee the safety of trial participants.

• Engage in activities aimed at recruiting and retaining participants for trials.

• Present medical topics during kick-off and investigator meetings.

• Educate trial teams on therapeutic areas and the medical components of protocols.

• Create and assess trial-specific medical monitoring documents.

• Manage ongoing medical monitoring risks associated with the trials.

• Conduct continuous medical reviews of operational clinical trial databases.

• Assist Medical Reviewers who are assigned to trials.

• Evaluate protocol deviations, RAE reports, SAE narratives, IND/SUSAR safety reports, and clinical study reports.

• Collaborate with Pharmacovigilance, Medical Data Review, and Data Management for safety and database reconciliation.

• Take part in trial-related committees, such as IDMC and adjudication committees.

• Prepare for and engage in trial audits, following up on audit findings.

• Contribute to feasibility assessments for potential and ongoing trials in the specified country/region.

• Participate in bid defense meetings and engage with clients.

• Act as a medical expert, offering therapeutic knowledge to other departments within PSI.

⛳️ Requirements

• A Medical Doctor degree is necessary.

• US Board Certification in Gastroenterology is mandatory.

• At least 10 years of experience in practicing Gastroenterology is required.

• Experience in Clinical Research is preferred.

• Proficiency in MS Office applications is essential.

• Strong communication, presentation, and analytical abilities are needed.

• Must possess problem-solving skills, be team-oriented, and detail-focused.

• Must not need work visa sponsorship for current or future employment.

• Candidates must be located in the United States.

🏝️ Benefits

• Employees have the flexibility to work remotely.

• Full-time employment opportunities are available.

• Join PSI's international Medical Monitoring team.

• Career development opportunities at the forefront of medical science.

• Utilize medical expertise to assist in bringing new medications to patients.