Senior Quality Assurance and Control Associate - Clinical Research

Baylor College of Medicine; Texas; Ibrido; USD 79.000 - 93.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work model

Certification pay

Descrizione del lavoro

Baylor College of Medicine in the Greater Houston area is seeking a Senior Quality Assurance and Control Associate to provide independent quality oversight of clinical research, ensuring FDA, ICH-GCP, sponsor, and institutional compliance across study documentation and processes.

The role leads audits, maintains audit readiness, and supports corrective actions, with the hybrid work arrangement; CCRP/CCRC certified staff may receive certification pay; the position requires a Bachelor's degree and

Competenze

• Bachelor's degree.
• Four years of relevant experience.
• Experience in clinical research quality assurance and regulatory compliance.
• Experience leading or supporting sponsor audits and inspections.

Mansioni

• Provide independent, risk-based QA oversight across clinical study portfolio.
• Lead and support audits and regulatory inspections, including FDA inspections.
• Coordinate inspection readiness activities and CAPA.
• Contribute to education and training in quality and compliance.

Conoscenze

Quality oversight

Regulatory compliance

Audit management

GCP knowledge

Formazione

Bachelor's degree

Descrizione del lavoro

Senior Quality Assurance and Control Associate - Clinical Research

Division: Pediatrics
Work Arrangement: Hybrid
Location: Hybrid within Greater Houston, TX
Salary Range: $79,092 - $93,000
FLSA Status: Exempt
Work Schedule: Monday – Friday, 8 a.m. – 5 p.m.

Summary

The Senior Quality Assurance and Control Associate provides independent quality oversight of clinical research activities to ensure compliance with FDA regulations, ICH–Good Clinical Practice (ICH-GCP), sponsor requirements, and institutional policies. This role leads and supports internal audits, sponsor audits, and regulatory inspections, including FDA inspections, and ensures the accuracy, completeness, and integrity of clinical study documentation and processes. The position is critical to maintaining continuous audit readiness, identifying and mitigating compliance risks, and supporting the ethical, safe, and compliant conduct of clinical research.

After initial training and onboarding, the position is a hybrid role typically working 2 days in office each week.

Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.

Job Duties

Clinical Research Quality Oversight (50%)

• Provide independent, risk-based oversight across a large and diverse clinical study portfolio to ensure compliance with FDA regulations, ICH-GCP, sponsor requirements, and institutional policies.
• Plan, schedule, and conduct routine quality reviews of regulatory documentation, study conduct, source documentation, pharmacy and other study-related materials to support continuous audit readiness and participant safety.
• Identify compliance risks, trends, and recurring issues; communicate findings to leadership and key stakeholders.
• Provide guidance to investigators and research staff on corrective and preventative actions (CAPA).
• Support noncompliance management activities, including documentation, escalation as appropriate, and coordination of retraining and process improvements.

Audit and Inspection Management (30%)

• Lead and support internal audits, sponsor audits, and regulatory inspections, including FDA inspections.
• Coordinate inspection readiness and preparation activities, including documentation reviews, inspection logistics, and staff interview preparation.
• Document audit/inspection findings clearly and accurately; track issues through resolution.
• Oversee CAPA development, implementation, effectiveness checks, and close-out to ensure timely, sustainable corrective action.

Education, Training, and Continuous Improvement (20%)

• Support and contribute to clinical research education initiatives, including development and delivery of quality and compliance training programs.
• Provide onboarding and investigator training related to GCP, documentation standards, regulatory expectations, and audit preparedness.
• Serve as a quality and regulatory resource to investigators, research staff, and leadership, supporting consistent application of quality standards across CRA and TCRI.
• Perform other job-related duties as assigned.

Minimum Qualifications

• Bachelor's degree.
• Four years of relevant experience.

Preferred Qualifications

• Experience in clinical research quality assurance, quality control, regulatory compliance, audit oversight, or related functions.
• Demonstrated experience leading or significantly supporting sponsor audits and regulatory inspections, including FDA inspections.
• Strong working knowledge of FDA regulations, ICH–GCP, institutional policies, and sponsor requirements.
• Experience developing and maintaining SOPs, CAPA programs, and risk-based quality oversight frameworks.
• Ability to identify documentation deficiencies, inconsistencies, and process gaps, and implement effective, compliant solutions.
• Ability to independently lead and manage quality reviews and communicate results with appropriate sensitivity and professionalism.
• Excellent written, verbal, and presentation skills, with the ability to communicate effectively with leadership, investigators, research staff, sponsors, and regulatory representatives.

Work Authorization Requirement:

This position is not eligible for visa sponsorship. Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

Baylor College of Medicine fosters diversity among its students, trainees, faculty, and staff as a prerequisite to accomplishing our institutional mission and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care. Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.