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 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%
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