Director - Clinical Research Quality Assurance

Memorial Healthcare System; Florida; On-site; USD 120,000 - 180,000; Full time

Job summary

Memorial Healthcare System in Florida seeks a senior leader to oversee clinical research compliance and quality assurance. The role requires strong knowledge of FDA, HIPAA, ICH-GCP, and OHRP guidelines, with experience directing research operations.

You will ensure adherence to federal regulations, conduct audits, and mentor teams, with eight years in clinical research and four years in leadership. A Bachelor's is required; Master's preferred and professional certifications are encouraged.

Qualifications

• 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.

Skills

Critical thinking

Effective communication

Organization skills

Decisive judgment

Stress management

Education

Bachelor’s degree in healthcare, nursing, science or related field

Master’s degree preferred

Job description

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.

Memorial Healthcare System is a community of caregivers dedicated to delivering quality patient- and family-centered care. This passion for caring extends to our teammates, who support one another and create heartfelt connections that last a lifetime. We are one family at the heart of exceptional care. Join us as we elevate the well-being of everyone we touch. #teamMHSflorida