FHI 360 recrute 01 Clinical Research Associate
Localisation Dakar / Sénégal
Expiration 20 Mai 2017
Description de l’offre
Clinical Research Associate
Descriptif du poste
FHI 360’s Global Research Services (GRS) helps support and conduct clinical research in low-resource settings around the world. Our team includes clinical project managers, clinical research associates, research assistants, laboratory technologists, laboratory auditors, document specialists and instructional designers.
With culturally sensitive and multilingual employees in the United States, Africa, Asia, Latin America and Europe, GRS offers CRO services to government and private sponsors, including:
Project management
Protection of participants’s safety and rights
Site identification, evaulation and development
Site monitoring, management and training
Research operations
Laboratory capacity building, auditing, and training
Logistical support
Job Summary / Responsibilities:
-The Clinical Research Associate (CRA) monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols.
– Assists in the preparation of routine 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, may require supervision.
– Complete accurate monitoring visit reports.
– Develops training materials and conducts training for study implementation based on company policies and SOPs.
– Contributes to the development of and implements protocols and informed consents for research studies.
– Provides guidance on any protocol related issues.
– 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.
Travel required will be greater than 25%
Qualifications:
– Bachelor’s degree or its international equivalent in Health, Behavioral, Life or Social Sciences or other fields related to international/ human development. Master’s degree preferred
– 3 – 6 years of previous clinical research experience
– 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 – Effective organizational and time management skills
– Effective interpersonal skills
– Proven flexibility and adaptability
– Ability to work in a team or independently as required
– Proficiency in Microsoft Office, spreadsheet software and other technology required
– Articulate, professional and able to communicate in a clear, positive fashion with clients and staff
– Must be able to read, write and speak fluent French and English
This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
We offer competitive compensation and an outstanding benefit package. Please click here to visit FHI 360’s Career Center for a list of all open positions.
FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is an equal employment and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, disability, veteran status, genetic information or any other status or characteristic protected under applicable law.
To apply, follow the link below.
Coordonnées de l’offre
To apply, follow the link below https://jobs-fhi360.icims.com/jobs/18404/clinical-research-associate-ii/job?mobile=false&width=675&height=500&bga=true&needsRedirect=false&jan1offset=0&jun1offset=0