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

Required Skills/Abilities:

• Demonstrate a high level of professionalism and responsiveness when interacting with internal and external customers
• Strong communication skills with the ability to develop and maintain positive working relationships with research staff and other team members
• Proficient in computer skills including EMR and Microsoft Office.
• Strong knowledge of medical terminology.
• Maintain continuing education hours as required.
• Maintain all licenses, certifications, and qualifications current as required.

Certifications/Licenses/Education/or Experience in a related field:

• Bachelor’s, Master’s, or higher education
• At least 3 years’ experience in clinical research preferred
• At least 1 year of experience with quality control/assurance, auditing, compliance, FDA regulations, ICH/GCP, and industry expectations preferred
• CCRP, CCRC, or equivalent preferred

Physical Requirements:

• Sitting for prolonged periods of time at a desk.
• Computer use that requires visual acuity, typing, use of mouse/keyboard, and staring at a screen for extended periods of time.
• Occasionally lifting objects of up to 25 pounds such as files, office supplies, assisting patients when needed, etc.
• Walking and standing for continuous periods around the office or clinic as needed.
• Fine motor skills for tasks like typing, writing, handling small objects or equipment and materials.
• Adequate mobility for daily interactions, delivering packages throughout the clinic daily, and traveling between company locations as needed

Work Environment:

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of the job. Reasonable accommodation may be provided to enable individuals with disabilities to perform essential functions.
• Due to the nature of our business and the use of radiation and hazardous chemicals, it is imperative that all employees foster a culture and environment of safety.
• Safety Sensitive: In accordance with Arkansas code this position is designated as a safety sensitive position wherein the employee performing the job duties under the influence may constitute a threat to health or safety.

Highlands offers a full suite of benefits that includes those pictured below and MANY MORE...

• Certified a Great Place to Work!