Clinical Research Associate Job Vacancy at FHI 360 in Nairobi, Kenya

Job Title: Clinical Research Associate I

Job ID: 15048

Job Sector : Global Research & Services

Job Location: Nairobi-Kenya

Employer: FamilyHealth Initiative 360

About FHI 360:

FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in Health, Education, Nutrition, Environment, Economic Development, Civil Society, Gender, Youth, Research and Technology; creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries, all 50 U.S. states and all U.S. territories. We are currently seeking qualified candidates for the position of: Clinical Research Associate I

Project Description:

The CRA I will work closely with clinical and project management teams on a recently awarded contract with a leading pharmaceutical firm.  This position will be located in Nairobi, Kenya.  The CRA I will monitor activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. S/he will review regulatory documents as required and prepares site visit reports. The CRA I may participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing informed consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on a monitoring strategy, and/or developing project-specific training.

Job Overview:

• Assists in the preparation of protocols, informed consents, SOPs, and other appropriate documentation.
  

• Monitors clinical trials to ensure subject safety and compliance with the study protocol, FDA regulations and ICH/GCP Guidelines, may be done with supervisor.
• Coordinates necessary activities required to set-up, monitor, and close-out clinical trials sites
• Conduct site assessment, initiation, routine, and close-out monitoring visits.
• Complete accurate monitoring visit reports.
• Develops training materials and conducts training for study implementation based on company policies and standard operating procedures (SOPs), budgets, and quarterly and annual reporting.
• Must have a working knowledge of concepts, practices and procedures for conducting clinical research studies.
  

Job Requirements:

• BS/BA or its international equivalent in Health, Behavioral, Life or Social Sciences or other fields related to international/ human development with 5-7 years of experience in some area of clinical research or MS/MA with 3-5 years of experience in some area of clinical research.

• One year of previous experience as a clinical research associate preferred.
• Strong analytical skills and ability to organize diverse information in a systematic way are essential
• Excellent interpersonal, oral/written communication, and organizational skills
• Ability to work in a team consisting of people with different technical backgrounds and with people with varying levels of training
• Ability to facilitate relationships and interact smoothly and effectively with clients and colleagues.
• Proficiency in Microsoft Office, spreadsheet software and other technology required
• Strong knowledge of software programs used to collect data and track risk based monitoring parameters
• Ability to analyze and interpret data, identify errors and prepare reports.
• Exceptional attention to detail
• Ability to travel up to 50% of the time.
• Good oral and written communication skills.
• Articulate, professional and able to communicate in a clear, positive fashion with clients and staff.
• Experience with pharmaceutical firms or CROs a plus.
  

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