CRA I
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 seek qualified candidates for the
position of Clinical Research Associate I (CRAI) with the Global
Research Services Department’s various locations in Africa and Asia
Project Description:
GRS partners with public and private medical
research organizations, including the U.S. National Institutes of Health, the
U.S. Centers for Disease Control and Prevention, the U.S. Agency for
International Development, academic institutions, and pharmaceutical and
biotechnology companies to set up, manage and monitor clinical research trials.
Our services support Phase I to Phase IV
clinical trials and the conduct of observational, ecological and behavioral
research studies. Our areas of expertise
include: site identification and development, developing capacity-building
strategies, evaluating clinical and central laboratories and recommending
quality and capacity enhancements.
Position Description:
The
CRA I will work closely with clinical and project management teams on a
recently awarded contract with a leading pharmaceutical firm. These positions may be located in either
West, Southern, or Eastern Africa; or Southeast Asia. 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 Responsibilities:
- 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.
Minimum
Requirements:
- Bachelor’s degree or its international equivalent in Health, Behavioral, Life or Social Sciences or other fields related to international/ human development.
- Requires at least one year of previous clinical research experience.
- 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.
- Demonstrated managerial, leadership, organizational, and interpersonal skills.
- 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. Field experience in developing countries is essential. Previous work in partnership with ministries of health, national AIDS commissions, or other national and local organizations is essential.
- Experience with pharmaceutical firms or CROs a plus.
- High level of fluency in spoken and written French may be required for some positions.
Interested candidates may submit CV/resume and cover letter including salary requirements to indo-hr@fhi360.org. Please specify source in your
application.
