Clinical Research QA Specialist

Saratoga Ascend; Oregon; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Saratoga Medical is seeking a Remote Clinical Research QA Specialist to oversee quality assurance in NIH/FDA-regulated studies. You will develop monitoring SOPs, review regulatory files, and lead CAPA processes while ensuring GCP compliance.

Ideal candidates have 5+ years in clinical research QA, strong documentation skills, and the ability to work in a multidisciplinary team with regulators and investigators. Remote position available in the United States.

Qualifications

• Develop and maintain monitoring SOPs and quality management documents.

Responsibilities

• Develop and maintain monitoring SOPs and quality management documents.

Skills

SOP development

Quality management

CAPA tracking

Internal audits

GCP training

Regulatory documentation

Education

Bachelor's degree in life sciences

Job description

Saratoga Medical is hiring a Remote, Clinical Research QA Specialist.

Package includes competitive rate and benefit options.

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.