Job description

Brief Description:

The medical person will be responsible for providing medical input on key study documents (e.g., Medical Monitoring Plan, ICF, eCRFs, etc.), as well as monitoring subject eligibility and safety. The medical person will also provide input on the medical interpretation of safety data in clinical trials.

Essential Functions

• Provide input on selection of Investigators/Sites for clinical trial

• Review and approve medical/scientific and safety content of the master ICF in collaboration with Drug Safety Lead

• Work with Data Management and Clinical Operations for the planning and execution of data review activities, including a medical monitor plan when indicated • Conduct eligibility reviews of screened trial participants • Review and provide input into design of eCRF, eCRF Completion Guidelines, edit specifications, and the design of other systems (IRT, ePRO, etc.). Test relevant systems as appropriate.

• Review Statistical Analysis Plan (SAP).

• Consult with Investigators on inclusion/exclusion criteria decisions regarding subject safety and protocol adherence

Job Types: Full-time, Contract

Schedule:

• 8 hour shift

License/Certification:

• Medical License (Preferred)

Willingness to travel:

• 25% (Preferred)

Work Location: Remote

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