What are the responsibilities and job description for the Research Quality Assurance Supervisor position at Highlands Oncology Group?
We are seeking a Quality Assurance Supervisor to lead quality and compliance efforts within our Research Department at a private oncology clinic. This role is instrumental in safeguarding research integrity, strengthening quality systems, and ensuring our clinical trials meet the highest regulatory and ethical standards—ultimately supporting exceptional patient care.
Highlands Oncology began in 1996 with three physicians and a desire to change the face of oncology care in our community. Dr. Malcom Hayward, Dr. Dan Bradford, and Dr. Thad Beck knew that patients do better at home, in the community where they live and work, and where their support system is already in place. In furthering that goal, Highlands has grown with the region from a single location 26 years ago, to 6 locations in Northwest and Northcentral Arkansas today employing more than 850 diverse team members.
As Northwest Arkansas continues to grow, so must the services and providers available in the research. Highlands Oncology is committed to remaining on the cutting edge to ensure our community has access to the very best cancer care. What we have is something quite unique right here in our own backyard with a caring multidisciplinary team focused on treating patients like family.
The Research Quality Assurance Supervisor is responsible for evaluating clinical trial patient charts and regulatory documents for quality and compliance with federal guidelines. The Research Quality Assurance Supervisor will maintain and develop quality assurance processes and procedures that adhere to FDA regulations, Good Clinical Practice guidelines, Highlands Oncology policies and procedures, and sponsor requirements.
The Research Quality Assurance Supervisor oversees the Clinical Research Associates and Clinical Research Consultants.
Job Duties / Responsibilities:
- Supervise quality team members, act as back-up as necessary
- Supervise day-to-day operation of the quality team
- Lead end-to-end audit preparation by coordinating documentation, aligning teams, and ensuring all departmental processes, controls, and records meet compliance standards
- Participate and assist with audits from regulatory agencies and/or sponsors
- Maintain a quality assurance program to provide internal auditing of the research department
- Demonstrate knowledge of regulatory requirements (FDA, IRB, GCP, ICH, SOPs, etc.)
- Review and assess internal processes
- Develop and update standard operating procedures (SOPs) and working practices
- Write audit response letters and corrective action plans
- Conduct ongoing review of findings with root cause analysis of common deficiencies
- Present quality findings to administration
- Verify subject eligibility for enrollment and associated source documents
- Review informed consent documentation
- Maintain oversight of informed consent form updates, ensuring timely documentation, regulatory adherence, and consistent communication across clinical and operational teams.
- Conduct training and education for research staff on compliance, policies, and regulations
- Oversee the tracking, documentation, and timely reporting of serious adverse events