Description and purpose:
The Study Coordinator/Medical Officer will provide expert service in the examination, treatment and follow up of study participants and completion of study documentation in accordance with the study protocol, Good Clinical Practice, applicable institutional policies and MU-JHU standard operating procedures.
Required qualifications and profile:
A degree in Medicine (MBChB) with at least 3 years’ working experience in clinical trials and good clinical skills in a busy health institution. Possession of a relevant clinical Master’s degree and previous working experience in a clinical research setting would represent additional relevant qualification and experience. The desired person must be able and willing to work independently, multi-task and possess strong judgement, communication and interpersonal skills and a strong commitment to client service.
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The holder of this position will work under the supervision of the Program Manager, with guidance of the Director Clinic Division and will be responsible for the following:
- Oversee and coordinate the day to day activities of the study and ensure collection of quality data and participate in study participant’s recruitment.
- Coordinate the Medical Officers and nursing/midwifery staff involved in the study and ensure that all staff are correctly carrying out their duties as relates to the study protocol and regulatory requirements.
- Ensure proper documentation is in place as per stipulated in protocol and participate in quality control (QC) of documentation.
- Liaise with hospital staff and the study staff to ensure coordination and minimize interference between study activities and routine clinic work at the Paediatric and Neonatal OPD and Wards, Labour and Postnatal Wards.
- Compilation and presentation of study updates/reports.
- Identification, recording and participant review for any potential SAE according to the study protocol timelines
- Review of participant diary cards in real time for any potential SAE that require prompt action (e.g. allergic reaction, fever.)
- Ensure all admitted study mothers and babies are review by the study obstetrician and pediatrician respectively.
- Ensure samples are collected according to SOP, correct sample labeling and documentation and proper tracking
- Ensure that all results are received in a timely manner and acted upon by the study and clinical teams
- Ensure that all infants are screened for signs of infection prior to discharge.
- Develop and generate study documents e.g. source documents, study specific standard operating procedures, consent forms, etc.
- Patient physical examination thoroughly done, particularly life-threatening conditions/illness, nutrition, growth and developments taken and findings accurately documented.
Applications with complete C.Vs, including 3 referees and their full addresses or contact Tel No.’s, copies of academic certificates and testimonials, should be emailed to HR@mujhu.org or hand delivered to: MU-JHU Reception Room 12, located in MU-JHU 1 Building – not later than 9th February, 2023 by 5:30p.m. Only short listed applicants will be contacted.