Job Title: Study Coordinator
Location: Yaounde, Cameroon
Reports to: Associate Director of Public Health Evaluation
Contract Duration: 2 years starting in October 2018
Terms of Offer: This position is remunerated on local terms.
"Sometimes in life there is that moment when it's possible to make a change for the better. This is one of those moments." -Elizabeth Glaser
The Elizabeth Glaser Pediatric AIDS Foundation is a global leader in the fight against pediatric HIV and AIDS, working in 15 countries and at over 5,500 sites around the world to prevent the transmission of HIV to children, and to help those already infected. Today, because of the highly successful work of the Foundation and its partners, pediatric AIDS has been virtually eliminated in the United States. With a growing global staff of over 1,000—nine of 10 who work in the field—the Foundation’s global mission is to eliminate pediatric HIV and AIDS by implementing HIV prevention, care, and treatment programs; further advance innovative research; and to execute strategic and targeted global advocacy activities to bring dramatic change to the lives of millions of women, children, and families worldwide.
The goal of the UNITAID CAP-TB project is to reach more children who are suffering from tuberculosis (TB) by using innovative models of TB care for children and improving the market for child-friendly TB medicines. One innovative research project is the integration of pediatric TB services into child healthcare units and at all the child entry point in health facilities (INPUT study). The INPUT study is a cluster-randomized intervention study using a stepped wedge design to compare two strategies for case detection and management of tuberculosis in children under the age of 5 years. This study will compare the standard of care, which offers pediatric TB services based on current routine approach in the country and the intervention, which will offer pediatric TB services integrated into key child healthcare services, as part of the UNITAID CaP TB package.
The study coordinator will be responsible of the preparation, implementation and coordination of the CAP-TB INPUT study in Cameroon. He/she will oversee a team of study nurses, a data manager and a study monitor. He/she will report to the country principal investigator and trial manager on study-related aspects and will be under the supervision of the Associate Director of Public Health Evaluation.
During the study preparation:
> Coordinate the assessment and preparation of the study sites in Cameroon.
> Manage the recruitment of the study staff (data manager, clinical research assistant, study nurses, field workers, monitor).
> Review and ensure the local validation of the study Case Report Forms (CRF), consent forms, Standard Operating Procedures (SOPs).
> Coordinate the protocol submission to the local ethical and administrative committees.
> Ensure with the data manager that all study sites have data collection tools in place.
> Organize the local training of the study nurses and the community healthcare workers (CHWs) according to the GCP.
> Coordinate with the principal investigator and the trial manager the site opening visit. During the study recruitment:
> Ensure that the recruitment takes place as planned in all study sites and provide support when needed.
> Monitor the progress of the study according to the protocol, SOPs and the GCP.
> Coordinate the submission of any protocol amendments to the ethical and administrative committees.
> Ensure that the sensitive information (signed consent forms) is well kept according to the GCP
> Ensure the completeness of the site investigator file
> Participate in the study meetings with the country PI, with the trial manager and the research/institutional meetings of EGPAF on regular basis
> Immediately report any serious adverse events to the country principal investigator, coordinating investigator, trial manager in the central research team and sponsor.
> Supervise and mentor the study staff on all study-related issues.
> Ensure that any study deviation is recorded and that major deviations are communicated on time to the regulatory authorities, trial manager and sponsor. If required, write a study progress report to the Ministry of Health (MOH) or other local health authorities.
1' Medical Doctor with an MPH degree in epidemiology, public health, or relevant field. 1' Knowledge and comprehension of human subjects’ research and of GCP.
v' Minimum of 3 years’ experience in operational research as research assistant, Study Coordinator, Study Manager or Monitor.
v' Experience with stepped wedge trials will be appreciated.
v' Experience in managing teams of study staff.
v' Excellent teamwork and coordination skills.
v' Excellent oral and written communication skills.
v' Perfect professional proficiency in English and French.
v' Availability to travel on the field on a regular basis
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