Join a world class team and help to bring cancer treatment HOME!

Highlands Oncology began in 1996 with three physicians and a desire to change the face of oncology care in our community. Dr. Malcolm 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 750 diverse team members.

As Northwest Arkansas continues to grow, so must the services and providers available in the region. 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.

Job Summary:

The Research Regulatory Supervisor is responsible for ensuring regulatory documentation is maintained and that clinical trial activities are conducted in compliance with Good Clinical Practice (GCP) guidelines, FDA, Highlands Oncology Group policies and procedures, and sponsor requirements. This position provides day-to-day leadership and oversight of research regulatory workflows and essential documents and is responsible for planning, assigning, and prioritizing projects and staffing coverage to support operational needs.

Supervisory Responsibilities:

The Research Regulatory Supervisor oversees the Research Regulatory Coordinators and participates in performance management processes in accordance with organizational guidelines.

Job Duties / Responsibilities:
Protocol Management
• Performs all study life cycle regulatory activities – IRB Submission, FDA Form 1572, financial
disclosure forms, training, and requesting study access for assigned internal team.
• Prepares/maintains protocol files accurately and in a timely fashion.
• Insures most recent protocols, amendments, and documents are filed appropriately.
• Maintains accurate and complete sponsor correspondence files.
• Provides support to the research team as requested.
• Coordinates and assists sponsor delegates and Clinical Research Associates with access, visits, and communication.
• Schedules and attends Site Initiation Visits.
IRB Responsibility
• Acts as a contact for all regulatory concerns.
• Submits protocol/ICF changes to the IRB in a timely manner.
• Maintains accurate and complete IRB correspondence files and follow-up actions.
• Insures the most recently approved versions of documents are available.
• Notifies research team of consent form and protocol changes when necessary.
• Submits site related Serious Adverse Events.
• Submits site related protocol deviations, if applicable.

Miscellaneous
• Answers the research department phone.
• Escort Clinical Research Associates from the front lobbies.
• Provide tours to sponsors/vendors/staff when needed.
• Scans source documents into eRegulatory platform, when applicable.
• Posts and tracks training of all new study materials.
• Maintains staff training certificates.

Required Skills/Abilities:
Communication Skills
• Demonstrates a high level of professionalism and responsiveness when interacting with internal and
external customers.
• Advises director or other appropriate individuals of problems or concerns.
• Utilizes appropriate channels of communication in accordance with organizational structure.
• Collaborates effectively with physicians, nurses, and ancillary departments.
• Acts as liaison between PI, sponsor, patient, research team, and IRB.
• Communicates routinely with director regarding start-up and close-out of trials.
• Demonstrates effective oral and written communication skills.
• Attends research department meetings when held.
• Schedule and host monthly regulatory team meetings.
Accountability/Dependability
• Maintains patient/sponsor confidentiality.
• Promptly reports to work at designated times.
• Maintains good attendance with no unexcused absences.
• Follows up on issues as appropriate.
• Supports and adheres to organizational decisions, policies, and procedures.
• Willingly accepts assignments and completes them in a timely manner.
• Attends required meetings/activities.
Organizational Skills
• Maintains organized files and office space.
• Effectively sets priorities.
• Demonstrates flexibility in schedule to accommodate workload.
• Submits routine reports on or before due date.
• Maintains at-a-glance protocol information in office.
Professional Growth and Professionalism
• Demonstrates professionalism in appearance/dress code consistent with policy of HOG.
• Seeks to increase skills through self-directed learning activities.
• Demonstrates initiative in seeking new projects and making corporate-related contributions.
• Willing to take continuing education courses as appropriate.
• Recognizes personal/professional limitations and strives for improvements.
• Acts as team member both corporately and within the individual setting.
• After achieving two years of research experience, it is preferred to test and pass the certification for
Certified Clinical Research Professional (CCRP).

Certifications/Licenses/Education/or Experience in a related field:
• 3 years’ experience in clinical research preferred
• CCRP, CCRC, or equivalent preferred

Physical Requirements:
• Must be able to lift up to 25 lb. in use of regular office equipment and supplies.
• May be required to help move study supplies received to the research office.
• Requires extensive desk and computer use.
• May have long periods of standing, walking, or sitting at a workstation.

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 made 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.

Additional Requirements:
• A resignation notice of a minimum of four (4) weeks is requested. Resignation notices must be submitted in writing to the director and Human Resources.

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

*Certified as a Great Place to Work.