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Clinical Research QA Specialist

Saratoga Ascend United States

5 h ago
Remote qa Senior (5-10 yrs) Full-time United States
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About the role

The Clinical Research QA Specialist will develop and maintain monitoring SOPs while conducting quality reviews of regulatory files and monitoring reports. They are also responsible for tracking CAPA effectiveness, supporting internal audits, and delivering GCP training to research staff.

What they look for

Quality Assurance Clinical Research GCP SOP Development CAPA Internal Audits Inspection Readiness Protocol Training Regulatory Compliance FDA Regulations NIH Regulations Documentation Analytical Skills Communication Skills Human Subjects Protections ICH E6

Requirements

Candidates must have a bachelor's degree in a life science and at least 5 years of experience in quality assurance or clinical research, including 3 years in GCP functions. Proficiency in NIH or FDA-regulated study requirements and relevant federal regulations is essential.

Benefits

Competitive rate

Full description

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.

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