Job Title: International Consultancy to support UNICEF Uganda with UNSDCF…
Lead Study Monitor Non-profit Jobs – Epicentre
Job Title: Lead Study Monitor
(M/F)
(M/F)
Organisation: Epicentre
Duty Station:
Mbarara, Uganda
Mbarara, Uganda
About US:
Epicentre is a
non-government organization created by Medecins Sans Frontieres (MSF) in 1987
to help improve the quality of its field interventions. Since 1996, Epicentre
has been a World Health Organization (WHO) collaborating centre for research in
epidemiology and response to emerging diseases. Epicentre’s work hinges around
three main activity areas: clinical research, field epidemiology and training.
The Ugandan Research Centre conducts research activities on public health
issues relevant to Africa, according to GCPs (Good Clinical Practices) quality
standards, in close collaboration with MSF, Mbarara University of Science &
Technologies, and other stakeholders in health sector. Current projects, inclu
clinical and vaccinal trials, focus on TB, HIV, central nervous system
infections, and yellow fever.
non-government organization created by Medecins Sans Frontieres (MSF) in 1987
to help improve the quality of its field interventions. Since 1996, Epicentre
has been a World Health Organization (WHO) collaborating centre for research in
epidemiology and response to emerging diseases. Epicentre’s work hinges around
three main activity areas: clinical research, field epidemiology and training.
The Ugandan Research Centre conducts research activities on public health
issues relevant to Africa, according to GCPs (Good Clinical Practices) quality
standards, in close collaboration with MSF, Mbarara University of Science &
Technologies, and other stakeholders in health sector. Current projects, inclu
clinical and vaccinal trials, focus on TB, HIV, central nervous system
infections, and yellow fever.
Job Summary: The Lead Study Monitor performs and coordinates
all aspects of the clinical monitoring and site management process in
accordance with ICH GCP, FDA guidelines, local regulations and Epicentre SOPs.
all aspects of the clinical monitoring and site management process in
accordance with ICH GCP, FDA guidelines, local regulations and Epicentre SOPs.
Key Duties and Responsibilities:
- Define the monitoring procedures, templates and documents related to
the studies and develop SOPs and MOPs - Responsible for managing the team study monitors and supervising all
monitoring activities (reports, follow-up letters, monitoring visits log,
product accountability…) - Assist the study team in logistics, site activation documents and
site training requirements - Activate clinical sites according to agreed timelines and quality
standards - Assure adherence to Good Clinical Practices, investigator integrity,
and compliance with all study procedures and all applicable laws - Support audit and manage required documentations, and ensure the
conformity of data with international quality assurance audits - Build and strengthen collaborative relationships with
investigational sites - Collaborate and work closely with the data-manager and statistician
of the studies - Support the laboratory department to monitor the timely sampling and
knowledge of transportation for samples and work closely with the
Laboratory Quality Control Manager
Qualifications, Skills and Experience:
- The Lead Study Monitor should have training in public health or
epidemiology - At least 10 years of experience in monitoring of research projects
- Good understanding of good clinical and participatory practice
- Strong experience in clinical research
- Demonstrate strong analytical, problem solving skills
- Strong written and verbal communication skills
- Detail oriented, good organizational traits
- Self-motivated, with strong leadership abilities
- Multi-tasking, quick learner, respond to the urgent needs of the
team and show a strong track record of meeting deadlines - Good computer skills and adapt easily to technology to maximize
efficiency
How to Apply:
All candidates
should send their applications online at the link below
should send their applications online at the link below
Deadline: 22nd June 2018
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