Description |
Contexte :
In 1995, Epicentre created a permanent research center in Uganda. The primary role of Epicentre in Mbarara is to conduct clinical research following Good Clinical Practice (GCP) requirements on critical public health burdens in Uganda and Africa. At present, the Mbarara Epicentre Research Centre is conducting 3 vaccine trials.
The Clinical Research Associate will work closely with the team in Mbarara, Uganda and Paris, France and will support the conduct of the 3 vaccine trials and ensure compliance with clinical trial protocols and GCP.
Activités principales :
- Preparation of protocols and regulatory support:
- Organizes and develops study related documents for submission of research protocols and any additional amendments to Ethics Review Boards (ERBs) and regulatory authorities
- Ensures proper contracts and documentations have been completed, communicated and any problems resolved and discussed
- Facilitates and organizes of all study related boards and committees including meetings, documentation and reimbursement contracts (DSMB, Scientific Committee, as well as punctual teleconferences with diverse partners)
- Diffuses results to relevant partners and stakeholders
- Participate in writing technical trial reports, including annual reporting to ERBs, MSF and partners
- Conduct of research :
- Identifies and assesses the suitability of facilities to use as the clinical trial site
- Ensures agreed upon hiring necessary to complete the project is conducted in a timely manner
- Regularly communicates with site instigators and vaccine trials coordinator to follow-up on the implementation of the trials and provide support and recommendations
- Monitors the trials throughout their duration, which involves visiting the trials sites on a regular basis
- Writes visit reports and follows-up on the action points
- Ensures the trials sites have the necessary materials, including investigational products, for the conduct of the studies, and follows-up on the accountability and ordering
- Participates in the training of the site personnel
- Helps in the development of Standard Operating Procedures and their revision as necessary
- Liaises with personnel in Paris office or outside to follow-up on specific issues, such as pharmacovigilance, laboratory activities, data management and statistics.
- Follow-up and revise budgets in coordination with finance team
- Project Closeout and Communication :
- Prepares submission of accurate and timely closeout documents to ERBs, MSF and external funders as appropriate
- Coordinates report diffusion to relevant partners and stakeholders with confirmation
- Ensures adequate final accountability of investigational products
- Supports the sites teams on the closures of the study site
- Coordinates the archiving of study documentation and correspondence
- Participates in Epicentre and MSF activities :
- Maintains and nurtures an interest in our collective activities and in the development of the organization as well as our guiding principles with respect to the conduct of research in vulnerable populations
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