SD Recruitment is looking for a Research Medical Officer for a 2 year contract position to start in August.
PURPOSE
1.
Clinical procedures
Activities / Objectives / Tasks (How)
Clinically assess, examine, diagnose and manage the health of participants.
Complete prescriptions of pharmaceuticals appropriately.
Monitor clinical examinations and procedures undertaken by study nurses when necessary.
Manage accountability and adherence monitoring of study drugs.
Refer participants to other clinical care as required.
Consult with other clinical and research staff when necessary.
Assist in maintaining good clinic flow.
Manage referral of participants to other clinics for additional care where applicable.
Results / Outcomes (Why)
Participants are managed according to South African Medical Council policies and procedures.
Participants are managed according to protocol requirements.
Participants are managed according to medical ethical standards.
2.
Protocol-specific procedures
Activities / Objectives / Tasks (How)
Ensure all research activities are performed according to Medical Control Council (MCC), protocol, the Declaration of Helsinki, International Conference On Harmonisation (ICH) Good Clinical Practice Guidelines and other relevant legislation.
Recruit, screen and enroll participants as per protocol-specific inclusion/exclusion requirements.
Ensure informed consent is obtained for all participants as per Standard Operating Procedures.
Manage participants with Adverse Events or Expedited Adverse Events and report as per protocol requirements.
Perform other protocol specific procedures when necessary (endoscopy, counselling, swabs, biopsies, etc).
Interpret and act on laboratory results.
Results / Outcomes (Why)
Recruitment is successful.
Participants remain on study.
Participant confidentiality maintained at all times.
Research protocol is followed correctly.
3.
Study Administration
Activities / Objectives / Tasks (How)
Document all procedures and investigations as per study requirements.
Assist in preparing study documentation for audits, monitoring visits and site visits from external study monitors.
Transcribe and ensure quality control of study documentation.
Attend clinical and research management meetings.
Assist with the design and enactment of standard operating procedures for clinical management and research projects.
Results / Outcomes (Why)
Study documentation is accurate and complete.
Research staff are supported.
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