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[Kelly Allen-Pitchko]

This role is intended to provide unbiased, 24/7, medical guidance to clinical sites and study operations teams. The medical monitor provides therapeutic and compound training, medical guidance on protocol compliance and coding of medical terms. The medical monitor supports clinical safety and data management by reviewing data listings. The medical monitor may also assist with the writing of the final study report. The medical monitor provides regular communication to the medical team (including medical teleconferences), and interfaces with sponsor Medical groups throughout the study.

AREAS OF RESPONSIBILITY:

Medical Oversight

Provide clarity on general protocol questions, and medical guidance for protocols as required.
Serve as medical expert providing guidance on patient eligibility matters, and investigational product related questions
Document contacts in accordance with Robarts or study specific procedures.
Consult with Robarts Medical Director(s), Sponsor Medical group and/or Safety with regard to medical questions pertaining to the indication under study.
Quickly identify safety issues as appropriate
Provide consultation on the unblinding of trial participants/site staff to subject treatment allocation
Review individual, out of range laboratory values following study-specific laboratory guidelines and alert values (as appropriate)
Review protocol deviation data and recommend protocol changes as appropriate
Follow a study-specific medical monitoring plan if applicable
Provide medical review of study level data, to identify gaps and areas requiring additional safety-related follow-up
Participate in the development, review and finalization of protocols, amendments, Clinical Study Reports, as required
Provide medical input into data collection tools, study plans (e.g., monitoring, statistical analysis plans, etc.
Provide medical input into study feasibility, site selection and site initiations as required
Attend and lead medical monitoring teleconferences at regularly scheduled intervals throughout the study, if required

Knowledge

Maintain a thorough working knowledge of protocol(s) and the current Investigator Brochure(s) with particular attention to those aspects relating to safety data involving human subjects

Training

Provide internal training to Alimentiv’s operational teams on specific diseases, drug targets, pharmacology, protocol requirements etc, as needed to support execution of client studies
Assist with the development of investigator training and meeting support materials.
Attend and present at investigator meetings and CRA training meetings.

QUALIFICATIONS:

Applicants should have a minimum of a Medical Degree (MD) and 3-5 years of relevant experience with significant job-related training. Further, the successful candidate will possess strong written and verbal communication and presentation skills, enabling effective interactions with team members within Alimentiv, client company personnel and prospective sponsors. Advanced understanding of drug development process, ICH and Good Clinical Practices (GCP) is required.

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