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

CO010 Memorial Healthcare System; United States; On-site; USD 140,000 - 200,000; Full time

Job summary

Memorial Healthcare System in Hollywood, FL seeks a Clinical Research Quality Assurance Director to provide strategic and operational oversight of the institution’s clinical research QA program.

You will ensure compliance with federal regulations, GCP, sponsor requirements, and human research protection standards while partnering with investigators and leadership to promote research integrity and audit readiness.

Qualifications

• Bachelor's degree in a healthcare, science or related field is required.
• Minimum 8 years in clinical research, with at least 4 years in leadership or managerial capacity.
• Experience overseeing QA, compliance, monitoring or research operations in academic medical centers or health systems.
• Strong knowledge of FDA, OHRP, ICH-GCP, HIPAA and related requirements.

Responsibilities

• Serves as a key resource during audits, inspections and accreditation activities with timely follow-up.
• Leads enterprise clinical research QA and monitoring programs, including routine and risk-based reviews.
• Develops, implements and maintains QA policies, SOPs and CAPA processes.
• Monitors evolving federal, state and sponsor requirements and integrates them into policies.
• Provides training and strategic guidance on GCP, FDA, OHRP, HIPAA and compliance.

Skills

Regulatory compliance

Auditing

Quality assurance

Leadership

GCP/ICH-GCP knowledge

Education

Bachelor's degree in Healthcare, Science, Public Health or related field

Master's degree preferred

Certifications such as CCRC/CCRP preferred

Job description

Location: Hollywood, Florida At 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 Performance Education

Education Requirements

Bachelors (Required)

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.

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.

Other Education Information

• Bachelor’s degree in Healthcare, Nursing, Science, Public Health or a related field
• Master’s degree in a related field preferred
• Relevant professional certification(s) such as CCRC, CCRP, CHRC, CIP, or equivalent preferred.

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 Information

Shift: Primarily for office workers - not eligible for shift differential

Disclaimer

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.

Salary & Inclusion

Wages shown on independent job boards reflect market averages, not specific to any employer.

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.

Veteran's Preference

Memorial Healthcare System provides preference as part of our commitment to honoring the service and sacrifice of veterans in alignment with state regulations. Veteran’s Preference allows for the first choice in interviewing, hiring, retention, and promotion after deployment when all other applicant qualifications are equal. However, Veteran's Preference does not guarantee a job. Who is eligible for Veteran’s Preference? We are proud to offer preference to internal and external applicants who identify within these categories: veterans, disabled veterans, spouse of a disabled veteran, unremarried veteran widow/widower, certain family members, active reservists and members of the National Guard. What should I do if I am eligible for Veteran’s Preference? You must claim your Veteran’s Preference status on your application. If selected for a job, you must provide documentation regarding your status. How does Memorial verify that someone is eligible for Veteran’s Preference? We require specific documentation as determined by the basis for which someone claims preference. For example, the documentation for a disabled veteran is different from the documentation required for the spouse of a veteran killed in the line of duty. How often can an eligible person claim Veteran's Preference at Memorial? There is no limit to how often internal or external applicants can use preference when a job is posted externally on our career website or elsewhere. What if there are two equally qualified, preference-eligible job applicants? In this case, the selection is based on the eligibility category in accordance with Florida law. First preference is given to: An honorably discharged veteran who has served on active duty and has a service-connected, compensable disability. A spouse of a person who has a total, permanent, service-connected disability and cannot qualify for employment. A spouse of a person missing in action, captured or forcibly detained or interned by a foreign government or power. What do I do if I feel I have been unfairly denied Veteran’s Preference by Memorial Healthcare System, please contact [e-mail]. You may also file a complaint with the Florida Department of Veterans’ Affairs (FDVA).

Other Policies

Florida Civil Rights Act Equal Employment Opportunity is the Law (EEO) Family and Medical Leave Act (FMLA) Employee Polygraph Protection Act (EPPA) E-Verify™ Participation Notice – English Right To Work Notice – English E-Verify™ Participation Notice – Spanish Right To Work Notice – Spanish Memorial Healthcare System is subject to the Florida Public Records Law. All information provided in connection with your application for employment will be a public record and subject to release upon request, unless considered exempt or confidential.