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Protocol Development & Review:

• Participates in protocol development, reviews and comprehends the protocol and other study materials;

• Attends investigator meetings;

• Develops clinical standard operating procedures and clinical report forms;

Community engagement and sensitization:

• Obtains informed consent, screens for study eligibility, enrols and follows up study participants;

• To screen individuals for possible inclusion in the study;

• To enrol eligible participants;

• To provide follow-up assessment and care to the enrolled participants; and ,

• To conduct home visits and visit hospital in-patients as required.

Clinical care:

• To carry out the clinical evaluation of participants and provide care as appropriate;

• To manage medical emergencies among study participants; and,

• To ensure appropriate referral as necessary.

Data collection and management:

• Participate in designing of Case Report Forms (CRFs);

• Collection of reliable and credible data as required by the protocol;

• Complete source documents and CRFs;

• Data entry and resolution of queries;

• Ensures completeness of CRFs submitted; and,

• Takes a lead role in cleaning of clinical data.

Prescription of Investigational Product (IP):

• To prescribe and where appropriate administer IP or request for study procedures for study Participants; and,

• To monitor study participants for efficacy and/or safety of the investigational product.

Administrative:

• To provide co-supervision of other team members such as field workers, nurses/counsellors and clinical officers during the day-to-day conduct of their work:

• Provide CME support to other staff as may be required; and,

• To order, monitor and ensure clinical and other supplies needed for study conduct are always adequate through appropriate projection of medical needs.

Intellectual:

• Contributes input into the design of the study;

• Participate in the analysis, write-up and presentation of the clinical results;

• To contribute to research and writing of scientific papers as required; and,

• Presentation and attending MUL science seminars and scientific conferences

PI designee duties:

• To identify, complete forms and report adverse events as appropriate;

• To identify, complete forms and report serious adverse events in a timely manner as appropriate ;

• To prepare study progress reports in liaison with the study coordinator and data manager;

• To apply and communicate with ethics and regulatory authorities; and,

• Perform any other duties assigned by the principal Investigator or supervisor.