Clinical Research QA Specialist

Saratoga Medical Center; United States; Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Benefits package

Job summary

Saratoga Medical Center is hiring a Remote, Clinical Research QA Specialist in the United States. The role focuses on ensuring GCP compliance and leading quality assurance activities for NIH- or FDA-regulated studies, including monitoring SOP development and CAPA effectiveness.

The ideal candidate has 5+ years of quality assurance or clinical research experience with at least 3 years in GCP roles, a life science degree, and QA certification preferred.

Qualifications

• Bachelor's degree in life science or related field.
• QA certification (e.g., CQA, RQAP-GCP) preferred.
• Minimum of 5 years of quality assurance or clinical research experience.
• At least 3 years in GCP quality functions for NIH- or FDA-regulated studies.
• Strong analytical, documentation and communication skills.
• Experience with ICH E6, 21 CFR Parts 11, 50, 54, 56, 312 and 812 where applicable.
• Current human subjects protections and GCP training (e.g., CITI).
• Experience collaborating with multidisciplinary teams including Government investigators and regulatory staff.

Responsibilities

• Develop and maintain monitoring SOPs and quality management documents.
• Quality review of monitoring reports, essential documents and regulatory files.
• Track and verify CAPA and effectiveness of corrective actions.
• Conduct or support internal audits and inspection readiness activities.
• Deliver GCP and protocol training for clinical research staff.
• Collaborate with multidisciplinary teams including regulatory staff and program officials.

Skills

Quality assurance

GCP knowledge

Regulatory compliance

Documentation

Audit readiness

Training delivery

Education

Bachelor's degree in life science or related field

QA certification (e.g., CQA, RQAP-GCP) preferred

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Clinical Research QA Specialist

Remote, US

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.