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.
- Product Sponsor and Product Development representatives will review all submissions.
- Documents will be audited by internal and external quality monitors. Success is assessed as acceptance by the FDA and positive review of information presented in the submission package.
- Documented compliance with CTC SOPs including training with SOPs, compliance with SOPs, and required maintenance of SOPs.
- Documented maintenance of all specified certifications and licenses.
- Documented continuing education in professional field (such as nursing) to maintain quality of technical skills.
- Documented continuing education in cGCP and human subjects protection to maintain quality of research and compliance with evolving regulations.
- Protocol specific deviation reports and results of internal and external monitoring and audits.
- All work done at the cGLP would be reviewed by the CTC Chief and COR.
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.