Deadline: 24 July, 2021
Location: Ghana
The Family Health International (FHI 360) is seeking applications from eligible applicants for the role of Clinical Research Associate.
FHI 360 delivers sustainable, high-quality, comprehensive HIV/AIDS prevention, treatment, care and support services.
Responsibilities
- Assist in the preparation of routine protocols, informed consent/assent forms, SOPs, and other appropriate study documentation
- Monitor clinical trials to ensure subject safety and compliance with the study protocol, applicable regulations and ICH/GCP guidelines
- Coordinate necessary activities required to set up, monitor, and close out clinical trial sites
- Conduct site evaluation/assessment, initiation, routine, and closeout monitoring visits
- Complete accurate monitoring visit reports
- Develop training materials and conduct training for study implementation based on company policies and SOPs
- Contribute to the development of and implement protocols and informed consent/assent for research studies
- Provide guidance on any protocol-related issues
- Manage budget to ensure CRA activities are completed as per contract
- Develop, review, and maintain key study documents to ensure adequate resource and reference documentation
- Serve as a liaison with internal and external partners to ensure effective collaboration efforts
- Oversee planning of meetings, site visits, and draft necessary documents
- Ensure compliance with applicable government regulations when writing and reviewing protocols, analysis plans, reports, and manuscripts
- Provide input with CRF development, analysis, study design, and material management
- Perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH good clinical practices, applicable regulations and FHI clinical SOPs
- Conduct site visit to assess protocol and regulatory compliance and manage required documentation
- Update and maintain study-specific tracking tools
- Function as project manager on assigned projects, taking on a lead role of achieving specific milestone goals
- Ensure data passes international quality assurance audits
- Represent FHI Clinical in the global clinical research community and develop and maintain collaborative relationships with investigational sites and clients
Requirements
- Bachelor’s degree or international equivalent in Education, Health Science, Behavioural Science, Life Science, Social Sciences, International Development, Human Development, or a related field
- Seven years, minimum, of clinical research experience, including assisting with protocol development, clinical monitoring, study implementation, study closeout, project management, analysis, and reporting
- ACRP or SoCRA certification
- Project or technical leadership experience
To apply and for more information, click here.
Photo source: Afya Uzazi Programme
