Support services will include conducting clinical research studies with experimental medical products under the principles of current Good Clinical Practices (cGCP), Good Laboratory Practices (cGLP), and Good Manufacturing Practices (cGMP). All of the work to support this research must be performed in accordance with the Federal, Department of Defense (DoD), and Command laws, regulations, and policies. Clinical research studies require production of experimental products, conduct of research studies, laboratory analysis of samples, analysis of resulting data, and submission of study findings.
Required Knowledge, Skills, and Abilities: Preferred knowledge of clinical research procedures; excellent interpersonal and computer skills; ability to communicate effectively and to work with individuals of all levels. The candidate should be well-organized; ability to follow detailed instructions; ability to handle multiple tasks; ability to meet deadlines of projects; ability to facilitate communication among supervisors, team members, and peers.
Minimum Education/Training Requirements: Bachelor’s degree in Science/Health-related field (i.e. Nursing, Medical Terminology, Biology or Biochemistry). A Master’s degree (within similar fields) is preferred and will equate to 1 – 3 years of experience.
Minimum Experience: 7-10 years of experience in clinical trial monitoring, or appropriate experience transferred from related occupation such as RA Specialist, Quality Assurance Specialist, and/or Site Coordinator. Certification as a Certified Clinical Research Profession (CCRP) or Certified Clinical Research Associated (CCRA) is preferred.