Summary of the Position:
The Research Physician is responsible for communicating with team members regarding the medical aspects of trial conduct, with particular emphasis on clinical interpretation, intervention, and review of medical information and results as well as the significance and impact thereof. Interact proactively with clients on medical and related issues during all phases of projects. Provide professional services relating to medical input into protocols, investigational drug safety, safety monitoring, and other pharmacovigilance-related activities. Apply medical knowledge and experience to the review and assessment of medical and safety data during trial conduct and post-trial analysis. Train and advise project team members on project-related medical issues, as warranted. Ensure adherence to all relevant and current clinical medical policies, directives, rules, regulations, and clinical performance standards of medical ethics and legal requirements of accrediting bodies.
Essential Functions:
Contribute to the development and review of protocols and their amendments.
Answer trial-related medical questions and interact with Clinical Operations and Regulatory Affairs colleagues, investigators and other site personnel on medical matters.
Review and advise on participant eligibility in consultation with Sponsors, as applicable.
Ongoing data review (including participant, safety, coding and protocol deviation/violation listings) and advise accordingly based on significance and/ or potential trial impact.
Review Data and Safety Monitoring Board (DSMB) reports.
Perform other functions of a medical monitor as defined for specific projects, including but not limited to development of Medical Monitoring Plans and eCRF input or review to ensure appropriate capture of medical data.
Perform, manage, co-ordinate and oversee trial-specific pharmacovigilance activities in collaboration with the designated project Safety Officer, including but not limited to: * Oversight of the development, review, and approval of Safety Management Plans and related safety reporting forms
MNCJobs.co.za will not be responsible for any payment made to a third-party. All Terms of Use are applicable.