Clinical Research QA Specialist
United StatesJust now
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Key details
- Location
- United States
- Work style
- Remote
- Level
- Senior
- Experience
- 5–8 yrs
- Function
- Software engineering
- Focus area
- QA / Test automation
- Posted
- Just now
Skills
About the role
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
Saratoga Medical Center, Inc. is an equal opportunity employer and will not discriminate in recruiting, hiring, training, promotion, transfer, discharge, compensation or any other term or condition of employment on the basis of race, religion, color, age (over age 39), sex, national origin, or on the basis of disability if the employee can perform the essential functions of the job, with a reasonable accommodation if necessary.