Medical Monitor (Part Time/Ophthalmology, GI, Oncology, CNS)

Job Title: Medical Monitor (Part Time/Ophthalmology, GI, Oncology, CNS)

Job Number: 31820

Location: Remote, 

Job Description

We’re looking for a Part-Time Medical Monitor, who will be responsible for providing input into the design and conduct of clinical trials, reviewing and/or generating key study documents (such as medical monitoring and safety management plans, treatment manuals, etc), assessing and interpreting safety data, and contributing to investigator, other site staff and clinical study team training. The Medical Monitor is the main point of contact for Investigators for medical and protocol related questions. You will provide medical knowledge and expertise to the day-to-day operations of clinical research studies by answering medical questions coming from the study team. You’ll report to our Director of Ophthalmology.

This role is part-time and fully remote, based anywhere in the US

Responsibilities

– Work as primary Medical Monitor for assigned clinical trials which includes being readily available to advise on trial related medical questions or problems during the conduct of the trial.
– Review and analysis of eligibility per inclusion/exclusion requirements of a clinical trial.
– This may include assessment of diagnostic imaging per protocol requirements
– Reviewing all adverse events to look for trends or risks, review all serious adverse events (SAEs), including review of the narrative, investigators’ assessment on causality, and applicable regulatory reporting.
– Provide review of study protocols and on-going medical oversight of clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
– Consult with internal and external stakeholders and experts to assist in the development and assisting in the design and conduct of clinical trials including the drafting of protocols and amendments.
– Assist with business development activities, including participation in bid defenses, and the development of business proposals as it pertains to Medical Affairs.
– Develop and/or review operational, medical monitoring, and safety plans for awarded studies.
– Assist in the study feasibility process by generating/reviewing feasibility questionnaires, identifying patient pathways, defining standard of care, and support site identification and selection.
– Lead and/or participate in scientific and medical training to other team members and outside clients, investigators, and other site staff as it pertains to assigned studies.
– This may include travel, attendance, and presentation at investigator meetings, symposiums, and/or conferences
– Monitor patient safety by acting as a medical monitor and/or in the development and conduct of a DSMB.
– Ensure activities related to SAEs are conducted in accordance with applicable SOP’s and regulations.
– Generate safety related documents, such as medical monitoring reports and the safety database, to ensure that the reporting of SAEs is current and complete.
– Write and/or review Safety Narratives, Investigator Letters, and other safety documentation for site-reported safety events.
– 24/7 emergency coverage for safety-related matters

Required Skills

– Doctor of Medicine (MD) with strong leadership skills including a minimum of 5 years direct experience in the pharmaceutical industry, preferably in a medical monitoring role, required.
– Relevant work experience in medical monitoring and/or pharmacovigilance and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment required.
– Proficient with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.