About the role
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.