CRA II
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 II (CRAII)
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 II 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 II 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 II 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.
- Effective clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Excellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures (SOPs).
- 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 SOPs.
- Manages and oversees budget for one or more research projects.
- Develops, reviews, and maintains key study documents to ensure adequate resource and reference documentation.
- May serve as a liaison with internal and external partners to ensure effective collaboration efforts.
- Oversees planning of meetings, site visits, and drafting necessary documents.
- Ensures compliance with government regulations when writing and reviewing protocols, analysis plans, reports, and manuscripts.
- Provides input with questionnaire development, analysis, study design, and material management.
- May serve as Lead CRA and oversee and train junior CRAs
- Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
- Strong organizational and time management skills
- Effective interpersonal skills
- Proven flexibility and adaptability
- Ability to work in a team or independently as required
- Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills
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 three years 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.
- Master’s Degree in Health, Behavior, Life or Social Science desirable.
- 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.
