FHI 360 is a global development organization with a rigorous, evidence-based approach. Our professional staff includes experts in health, nutrition, education, economic development, civil society, environment and research. FHI 360 operates from 60 offices with 4,400 staff in the U.S. and around the world. Our commitment to partnerships at every level and our multidisciplinary approach enable us to have lasting impact on the individuals, communities and countries we serve–improving lives for millions. We seek qualified candidates for the positions of Sr. Clinical Research Associate and Clinical Research Associate in Capetown, South Africa .
Clinical Research Associates (CRA) provide study and site management for FHI 360’s portfolio of clinical trials. The CRA evaluates the quality and integrity of study implementation in order to ensure the rights and safety of study participants, the high quality of data being collected, and adherence to all applicable regulations. The CRA also reviews study documents and data, and assists with resolving data queries. CRAs will conduct and report on site selection, initiation, monitoring and close-out visits according to good clinical practice.
In addition, the CRA will build and maintain relationships with sites to assist with the smooth implementation of the study, and provide training and guidance as necessary to site staff. The CRA will manage the progress of key study milestones, such as regulatory submissions and approval, recruitment, and retention. They will also create and maintain tools for tracking and implementation, study monitoring and communications plans, and other study implementation tools and escalate, as necessary, any project issues.
Health-related academic degree with prior clinical trial experience; Knowledge and skill in applying clinical research regulatory requirements such as Good Clinical Practice; (GCP) and International Conference on Harmonisation (ICH) guidelines; Computer proficiency and use of Microsoft Word, Excel and PowerPoint and use of a laptop computer; Strong written and verbal communication skills including good command of English language; Excellent organizational and problem-solving skills; Effective time management skills; Ability to manage competing priorities; Ability to establish and maintain effective working relationships with coworkers, managers and clients.
FHI 360 has a competitive compensation package. Interested candidates may go to FHI 360's Career Center at www.fhi360.org/careercenter or to the employment section at www.fhi360.org . Please submit CV/resume and cover letter including salary requirements, and specify source in your application.
FHI 360 - 21 months ago