Location: Orlando,FL, USA
** Minimum of five (5) years of experience in clinical research and quality assurance required**
As a top cancer care provider in Florida, Orlando Health Cancer Institute is a comprehensive, multidisciplinary cancer program consisting of six treatment sites and more than 10 practice locations that serve the regions adult oncology needs. Specializing in more than 200 types of cancer, an expert team of medical professionals provides personalized care with the most state-of-the-art technologies, such as advanced radiation and proton therapies, and bone marrow transplant and cellular therapy. Through a robust research program, the institute also supports physician involvement in numerous research studies and clinical trials that give patients access to innovative diagnosis, treatment and symptom management options. In addition to being accredited by the Commission on Cancer, a program of the American College of Surgeons, Orlando Health Cancer Institute has earned accreditations and certifications in several areas including medical oncology and hematology/oncology, radiation oncology, cellular therapy, rectal cancer, and breast care from the respective accrediting organizations, and recently was named in the 2023 Becker's Hospital Review 60 Hospitals and Health Systems with Great Oncology Programs list.
Orlando Health Cancer Institute is part of the Orlando Health system of care, which includes 24 award-winning hospitals and ERs, 9 specialty institutes, 14 urgent care centers, 100+ primary care practices and more than 60 outpatient facilities that span Floridas east to west coasts and beyond. Collectively, we honor our 100-year legacy by providing care for more than 142,000 inpatient and 3.9 million outpatient visits each year.
Orlando Health is committed to providing you with benefits that go beyond the expected, with career-growing FREE education programs and well-being services to support you and your family through every stage of life. We begin your benefits on day one and offer flexibility wherever possible so that you can be present for your passions. Orlando Health Is Your Best Place to Work is not just something we say, its our promise to you.
Position Summary
The Manager of Clinical Research Quality Assurance is responsible for overseeing and ensuring the compliance of clinical research activities with regulatory requirements and institutional policies. This role involves creating and managing quality assurance processes and procedures, conducting internal audits, and developing corrective and preventative actions to maintain high standards in clinical research quality.
**Oncology experience prefered**
Responsibilities:
Essential Functions
Develops and implements quality assurance strategies to ensure compliance with industry regulations, including 21 CFR Part 11, GDPR, and Good Clinical Practices (GCP). Conducts internal audits of clinical trials to ensure protocol compliance and adherence to Standard Operating Procedures (SOPs) and regulatory guidelines. Manages and coordinates the preparation and readiness for regulatory inspections and external audits. Collaborates with research teams to address and resolve compliance issues identified during audits. Develops and assesses corrective and preventative actions (CAPAs) to ensure continuous improvement in research quality. Provides training and guidance to research staff on quality assurance and regulatory compliance. Acts as a primary contact for internal and external audits, regulatory inspections, and other quality assurance activities. Maintains up-to-date knowledge of regulatory requirements and industry best practices in clinical research. Promotes interdepartmental cooperation and coordination to enhance overall quality and efficiency in clinical research. Attends and represent the organization at relevant meetings, including study group and investigator meetings. Conducts quality compliance assessments and provide feedback to senior leadership on the status of research quality assurance. Other duties as assigned. Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state, and local standards. Maintains compliance with all Orlando Health policies and procedures.
Other Related Functions
Develops standards and protocols for the QA team in preparing for site audits. Participates in departmental and corporate meetings as required. Conducts quality compliance assessments and provide detailed reports to senior leadership. Ensures effective communication and positive working relationships with research staff and external stakeholders.
Qualifications:Education/Training
Bachelors degree in a health-related field (e.g., Healthcare Administration, Nursing, Health Information Management). Masters degree preferred.Licensure/Certification Clinical Research Auditing Certification (i.e. CCRC/CCRP or QA/QI) or eligibility within one year of hire.
Experience
Minimum of five (5) years of experience in clinical research and quality assurance. Experience in managing large-scale or multi-site clinical trials is highly desirable. Demonstrable leadership skills and experience in coordinating research compliance activities.