Director - Clinical Research Quality Assurance - FT - Days - MHS

Memorial Healthcare System; Florida; On-site; USD 140,000 - 210,000; Full time

Job summary

Memorial Healthcare System seeks a Clinical Research Quality Assurance Director to provide strategic and operational oversight of the institution’s QA program in Hollywood, Florida. You will champion audits, CAPA, and continuous improvement to ensure GCP and regulatory compliance across research operations.

Leadershi p experience in academic medical centers or health systems, with deep knowledge of FDA, OHRP, ICH-GCP, and HIPAA requirements, is essential to ensure audit readiness and participant

Qualifications

• Bachelor’s degree in Healthcare, Nursing, Science, Public Health or related field.
• 8+ years of progressive core experience in clinical research, human research protections, research compliance, quality assurance, auditing, or related research administration functions.

Responsibilities

• Serves as a key institutional resource during audits, inspections, and accreditation activities, ensuring timely follow-up, risk mitigation, and resolution of findings.
• Leads and oversees the enterprise clinical research quality assurance and monitoring program, including routine, for-cause, and risk-based reviews.
• Develops, implements, and maintains QA policies, SOPs, CAPA processes, and quality improvement initiatives aligned with regulatory and accreditation standards.
• Monitors evolving federal, state, sponsor, and accreditation requirements such as ICH-GCP E6 updates and ensures timely integration into institutional policies, workflows, and practices.
• Provides training, education and strategic guidance to investigators, research staff, and leadership on GCP, FDA, OHRP, HIPAA, and institutional compliance requirements.

Skills

Leadership

Quality Assurance

Regulatory knowledge

Audit programs

Communication

Education

Bachelor's degree in Healthcare/Life Sciences

Master's degree preferred

Job description

Location:Hollywood, FloridaAt Memorial, we are dedicated to improving the health, well-being and, most of all, quality of life for the people entrusted to our care. An unwavering commitment to our service vision is what makes the difference. It is the foundation of The Memorial Experience.Summary:The Clinical Research Quality Assurance Director provides strategic and operational oversight of the institution’s clinical research quality assurance program, ensuring compliance with federal regulations, Good Clinical Practice (GCP), institutional policies, sponsor requirements, and human research protection standards. This role leads proactive quality and monitoring initiatives, drives continuous improvement, and partners with investigators, research leadership, compliance, IRB, and operational teams to promote research integrity, participant safety, and audit readiness.Responsibilities:Serves as a key institutional resource during audits, inspections, and accreditation activities, ensuring timely follow-up, risk mitigation, and resolution of findings.Leads and oversees the enterprise clinical research quality assurance and monitoring program, including routine, for-cause, and risk-based reviews.Develops, implements, and maintains QA policies, SOPs, corrective and preventive action (CAPA) processes, and quality improvement initiatives aligned with regulatory and accreditation standards.Monitors evolving federal, state, sponsor, and accreditation requirements such as ICH-GCP E6 updates and ensures timely integration into institutional policies, workflows, and practices.Provides training, education and strategic guidance to investigators, research staff, and leadership on GCP, FDA, OHRP, HIPAA, and institutional compliance requirements.Competencies:Business Acumen, Concern for Quality, Develop Relationships, Lead Through Vision, Manage PerformanceEducation and Certification Requirements:Bachelors (Required)Additional Job Information:Complexity of Work: Requires critical thinking skills, effective communication skills, organization skills, decisive judgment and the ability to work with minimal supervision. Must be able to work in a stressful environment and take appropriate action. In-depth knowledge of federal regulations governing human subjects’ research.Demonstrated expertise in FDA regulations, OHRP requirements, ICH-GCP guidelines, HIPAA/privacy regulations, and clinical research quality systems. Required Work Experience: A minimum of eight (8) years of progressive core experience in clinical research, human research protections, research compliance, quality assurance, auditing, or related research administration functions, including at least four (4) years in a leadership or managerial capacity.Prior leadership or management experience overseeing quality assurance, compliance, monitoring, or research operations within an academic medical center, health system, CRO, sponsor, or research institution preferred. Other Information: Additional Education Info: Bachelor’s degree in Healthcare, Nursing, Science, Public Health or a related fieldMaster’s degree in a related field preferredRelevant professional certification(s) such as CCRC, CCRP, CHRC, CIP, or equivalent preferred.Working Conditions and Physical Requirements: Bending and Stooping = 0% Climbing = 0% Keyboard Entry = 80% Kneeling = 0% Lifting/Carrying Patients 35 Pounds or Greater = 0% Lifting or Carrying 0 - 25 lbs Non-Patient = 0% Lifting or Carrying 2501 lbs - 75 lbs Non-Patient = 0% Lifting or Carrying > 75 lbs Non-Patient = 0% Pushing or Pulling 0 - 25 lbs Non-Patient = 0% Pushing or Pulling 26 - 75 lbs Non-Patient = 0% Pushing or Pulling > 75 lbs Non-Patient = 0% Reaching = 0% Repetitive Movement Foot/Leg = 0% Repetitive Movement Hand/Arm = 80% Running = 0% Sitting = 80% Squatting = 0% Standing = 80% Walking = 80% Audible Speech = 80% Hearing Acuity = 80% Smelling Acuity = 0% Taste Discrimination = 0% Depth Perception = 80% Distinguish Color = 80% Seeing - Far = 80% Seeing - Near = 80% Bio hazardous Waste = 0% Biological Hazards - Respiratory = 0% Biological Hazards - Skin or Ingestion = 0% Blood and/or Bodily Fluids = 0% Communicable Diseases and/or Pathogens = 0% Asbestos = 0% Cytotoxic Chemicals = 0% Dust = 0% Gas/Vapors/Fumes = 0% Hazardous Chemicals = 0% Hazardous Medication = 0% Latex = 0% Computer Monitor = 80% Domestic Animals = 0% Extreme Heat/Cold = 0% Fire Risk = 0% Hazardous Noise = 0% Heating Devices = 0% Hypoxia = 0% Laser/High Intensity Lights = 0% Magnetic Fields = 0% Moving Mechanical Parts = 0% Needles/Sharp Objects = 0% Potential Electric Shock = 0% Potential for Physical Assault = 0% Radiation = 0% Sudden Decompression During Flights = 0% Unprotected Heights = 0% Wet or Slippery Surfaces = 0%Shift:Primarily for office workers - not eligible for shift differentialDisclaimer: This job description is not intended, nor should it be construed to be an exhaustive list of all responsibilities, skills, efforts or working conditions associated with the job. It is intended to indicate the general nature and level of work performed by employees within this classification.Wages shown on independent job boards reflect market averages, not specific to any employer. We encourage candidates to talk to their Memorial Healthcare System recruiter to discuss actual pay rates, during the hiring process.Memorial Healthcare System is proud to be an equal opportunity employer committed to workplace diversity.Memorial Healthcare System recruits, hires and promotes qualified candidates for employment opportunities without regard to race, color, age, religion, gender, sexual orientation, national origin, veteran status, disability, genetic information, or any factor prohibited by law.We are proud to offer Veteran’s Preference to former military, reservists and military spouses (including widows and widowers). You must indicate your status on your application to take advantage of this program.Employment is subject to post offer, pre-placement assessment, including drug testing.If you need reasonable accommodation during the application process, please call 954-276-8340 (M-F, 8am-5pm) or email [e-mail]