Medical Monitor (US Board-Certified Gastroenterologist)

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.