| Company |
SAIC-Frederick, Inc. |
| Title: |
Clinical Research Associate II - Mali - 109702 |
| Category: |
Pharmaceutical |
| Description: |
| SAIC-Frederick, Inc., a subsidiary of SAIC, is the Operations and Technical Support Contractor for the National Cancer Institute at Frederick (NCI-Frederick) a federally funded research and development center. SAIC-Frederick, Inc. is one of four related NCI contracts on-site and serves as the infrastructure support for the entire center. The contract is the largest single research contract awarded by the Department of Health and Human Services (DHHS) and it is the department's only Government-owned, contractor-operated facility contract.
This position supports the Regulatory Compliance and Human Subjects Protection Branch and is located in Bamako, Mali. Provides monitoring of NIAID intramural research protocols and ensures that the clinical trials are conducted in a timely manner and in accordance with Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and all applicable regulatory guidelines. Responsible for opening, monitoring, and closing studies, clinical site management, and assists with managing the relationship with Clinical Research Organizations (CROs) and field Clinical Research Associates (CRAs) in Mali. Assists with designs, plans, and implementation of clinical trials (protocols, consent forms), as well as the management and coordination of project activities associated with the monitoring functions of clinical studies.
REQUIRED SKILLS: Possession of a Bachelors degree from an accredited college/university in a field related to biomedical research/clinical trials/health or four (4) years related experience in lieu of degree. Foreign educated candidates who have completed part or all of their education outside of the United States must have their foreign education evaluated by an SAIC-approved accrediting organization to assure that it has met the equivalency of the qualifications of degree work in the United States. In addition to education requirements, a minimum of two (2) years of progressively responsible experience in biomedical research including a minimum of one (1) year directly related to overseeing multiple concurrent trials. Verbal fluency and written proficiency in the French language. Must be willing to travel to the U.S. Familiarity with Malian culture. This position is subject to obtaining a Public Trust Clearance.
DESIRED SKILLS: Familiarity with regulatory requirements and guidelines for clinical research, as well as monitoring requirements. Infectious diseases experience is preferred. Knowledge of DHHS regulations is a plus. Experience with the development of CRFs and study monitoring plans. |
| Skills: |
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| Employment type: |
Full Time |
| Salary: |
Unspecified |
| Degree: |
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| Experience: |
2 |
| Location: |
Bamako - Africa - Mali |
| Post Date: |
03/04/2008 |
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