Program Monitor Job Vacancy – MRC/UVRI and LSHTM Uganda Research Unit
Organization: MRC/UVRI and LSHTM Uganda Research Unit
Duty Station: Entebbe, Uganda
Position Code: PM1119
Reports to: Head of Research Compliance and Quality Assurance
About US:
The Unit is an internationally recognised centre of excellence with dominant research themes in the areas of HIV and emerging infections, vaccines and immunity, and chronic diseases and cancer. Through a multidisciplinary approach, intersecting basic science, epidemiological research, social-behavioural research and the conduct of new intervention evaluation studies, the Unit contributes knowledge on changing epidemics and diseases, the evaluation of innovative health care options, treatment and prevention and the development of health policy and practice in Africa and worldwide. Following the signing of strategic transfer agreements between the London School of Hygiene & Tropical Medicine (LSHTM) and the
Medical Research Council (MRC UK), the Unit formally joined LSHTM on 1st February 2018.
The exciting new partnership will boost research capacity into current and emerging health issues in Africa and throughout the world. The Unit is based at the UVRI Entebbe campus with established outposts in Kalungu, Masaka, Wakiso and Kampala Districts.
Job Summary: The Program Monitor will support the research projects under Non-Communicable Disease
Theme to verify that; the rights and well -being of human subjects are protected, the reported trial data are accurate, complete and verifiable from source documents; and that the conduct of the trial is in compliance with the currently approved protocol/amendments/Standard
Operating Procedures, with Good Clinical Practice guidelines, and with applicable regulatory requirements at local and internal levels.
The Monitor will be required to familiarize themselves with the research protocols, informed consents, Standard Operating Procedures (SOPs), Good Clinical Practice and the applicable regulatory requirements.
Key Duties and Responsibilities:
- Assures adherence to all regulatory requirements by the local Ethics Committee,
- Uganda National Council of Science and Technology (UNCST) and any other Regulatory committees on record.
- Ensures that written procedures are followed and evaluates quality systems, processes, procedures, and protocols for compliance.
- Participates in developing SOP’s, guidance documents or other tools/templates pertinent to monitoring activities.
- Schedules and coordinates the activities for monitoring both by internal and external teams:
- Conduct the monitoring reviews of the trials including issuing data clarification queries as necessary.
- Writes monitoring reports and communicates monitoring results to Principal
- Investigators and study team.
- Manages post-monitoring activities and follow-up on any necessary corrective and preventive actions.
- Collaborates with PIs and staff to identify and implement ways to improve monitoring practices, procedures, and workflows.
- Work with PIs and project coordinators on training in Clinical Research Compliance and data management during site initiation visits and based on topics/gaps noted from monitor visits.
- Lead the preparation and maintenance of the investigator site file and trial master file.
- Should liaise with the PIs/Designee to develop and track studies for expiry and work with the study team to ensure that continuous approval is sought prior to study expiry
- Should ensure that adverse events and protocol deviation are appropriately documented and submitted within the timelines set by the ethics and regulatory bodies.
- Act as a point of contact for external monitors. S/he will notify and prepare site research teams on upcoming external monitoring visits/audits.
- Oversee the maintenance and tracking of research-staff CVs, GCP, HSP, SOP and protocol-specific trainings; and applicable practicing licenses as per local, international and sponsor requirements/ regulation.
- Ensuring that the operating licenses for the Unit Labs, Pharmacy and Clinics are up-to date.
- Maintain an inventory of all regulatory documents.
Qualifications, Skills and Experience:
- The ideal applicant should hold a Bachelor’s Degree in Nursing, Public Health, Health Service Management or related field.
- Possession of masters in a health related field is an added advantage.
- At least 5 years’ experience working in a research institution.
- Must have training in Good Clinical Practice or Good Clinical Laboratory Practice.
- Should be able to demonstrate a thorough understanding of local and international research guidelines.
- Should be able to demonstrate ability to provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific accuracy and clarity.
- Previous experience of implementing research study protocols.
- Knowledgeable in use of Microsoft Office packages.
- Organisation and management & communication skills (written and verbal) with ability to communicate throughout all levels of the organisation.
- Ability to work independently under pressure while meeting tight deadline
- Personal Integrity
- Emotional Resourcefulness
- Ability to Learn
- Forward Thinking
- Reliability
- Openness to Others
- Independence
- Results Orientation
- Thoroughness
- Concern for Excellence
- Flexible and dependable
- Service Orientation
- Development Orientation
How to Apply:
All interested and qualified candidates fill an online form accordingly by following the link below and there after submit your application documents to the e-mail below
Filling the form more than once will lead to automatic disqualification. High level of integrity while filling the form is required and will be considered during shortlisting.
Please email your application to recruitment@mrcuganda.org Applications should include academic documents, a cover letter, CV, daytime telephone contact and three traceable professional references. Combine all application documentation into one PDF document.
Only shortlisted candidates will be contacted for interview. The Unit reserves the right to verify documents attached with the relevant awarding institutions to authenticate their validity. This position is open to Ugandan nationals only.
NB: Please quote the following position code in the subject line of the email:
- Program Monitor: PM1119
Strictly follow the application procedure as failure to do so will lead to automatic disqualification of your application.
The applications should be addressed to:
The Human Resource and Administration Manager
MRC/ UVRI and LSHTM Uganda Research Unit
P.O.Box, 49
Entebbe, Uganda
Consider your application unsuccessful if not contacted within six (6) weeks after the closing date of the advert and any form of lobbying at any stage will lead to automatic disqualification.
MRC/UVRI and LSHTM Uganda research Unit is an equal opportunity employer committed to having a diverse work force and does not ask for money at any stage of recruitment.
Deadline: 15th November 2019