Saratoga Medical is hiring a
Remote, Clinical Research QA Specialist Package includes competitive rate and benefit options. Please see qualifications below and submit your resume if you are interested in being considered:
Education: Bachelor's degree in a life science or related field; QA certification (e.g., CQA, RQAP-GCP) preferred.
Experience: Minimum of 5 years of quality assurance or clinical research experience, including at least 3 years in GCP quality functions for NIH- or FDA-regulated studies.
Qualifications:- Development and maintenance of monitoring SOPs and quality management documents
- Quality review of monitoring reports, essential documents and regulatory files
- Tracking and verifying CAPA and the effectiveness of corrective actions
- Conducting or supporting internal audits and inspection readiness activities
- Delivering GCP and protocol training for clinical research staff
- Strong analytical, documentation and communication skills
- Five or more years of direct experience supporting NIH or FDA-regulated clinical research programs
- Working knowledge of Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312 and 812 (as applicable), 45 CFR Part 46, and HIPAA
- Current human subjects protections and GCP training (e.g., CITI or equivalent)
- Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff and program officials
