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.
Skills Required
- Bachelor's degree in life science or a related field
- At least five years of quality assurance or clinical research experience
- At least three years of GCP quality experience supporting NIH- or FDA-regulated studies
- Five or more years of direct experience supporting NIH- or FDA-regulated clinical research programs
- Working knowledge of ICH E6 Good Clinical Practice
- Working knowledge of 21 CFR Parts 11, 50, 54, 56, 312, and 812, as applicable
- Working knowledge of 45 CFR Part 46 and HIPAA
- Current human subjects protections and GCP training, such as CITI or equivalent
- Experience working with government clinical investigators, regulatory staff, and program officials in multidisciplinary teams
- QA certification such as CQA or RQAP-GCP
- Strong analytical, documentation, and communication skills
What We Do
Saratoga Ascend is a trusted healthcare, IT, and life sciences solutions and staffing partner supporting federal, state, and military agencies nationwide. With decades of experience in complex government environments, we deliver end-to-end solutions that strengthen workforce readiness, ensure regulatory compliance, deliver efficiency, and improve outcomes. We have expanded beyond our traditional staffing roots by providing comprehensive solutions and services in clinical and behavioural health, program design and management, credentialing and onboarding, call and contact center support, program management, data analytics, and technology-enabled services. Our expertise in transition and implementation allows agencies to reduce risk, maintain continuity, and achieve operational excellence from day one. At Saratoga Ascend, we are committed to helping our partners navigate complexity, scale effectively, and deliver mission-critical services with confidence, accountability, and measurable results. Our Certifications: SBA Certified Women - Owned Small Business Joint Commission Certified NMSDC Certified
