Research Regulatory Supervisor

Location and Contact 3901 Parkway Circle, Suite 100, Springdale, AR, 72762, United States Job Category research, clinical, regulatory Employment Type NonExempt – Full Time Team Structure Manages Others: Yes Job Summary The Research Regulatory Supervisor ensures regulatory documentation is maintained and that clinical trial activities comply with Good Clinical Practice guidelines, FDA regulations, Highland Oncology Group policies, and sponsor requirements. The role provides day‑to‑day leadership and oversight of research regulatory workflows and essential documents, and plans, assigns, and prioritizes 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 and 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 and maintains protocol files accurately and in a timely manner. Ensures the 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. Acts as a contact for all regulatory concerns. Submits protocol or ICF changes to the IRB in a timely manner. Maintains accurate and complete IRB correspondence files and follow‑up actions. Ensures the most recently approved versions of documents are available. Notifies the research team of consent form and protocol changes when necessary. Submits site‑related Serious Adverse Events. Submits site‑related protocol deviations, if applicable. Miscellaneous duties – Answers the research department phone, escorts Clinical Research Associates from the front lobbies, provides tours to sponsors, vendors, or staff when needed, scans source documents into the eRegulatory platform, posts and tracks training of new study materials, and maintains staff training certificates. Required Skills and Abilities Communication Skills – Demonstrates professionalism and responsiveness; advises leadership of problems or concerns; uses appropriate communication channels; collaborates with physicians, nurses, and ancillary departments; liaises between PI, sponsor, patient, research team, and IRB; communicates routinely with director; demonstrates effective oral and written communication; attends research department meetings; schedules and hosts monthly regulatory team meetings. Accountability and Dependability – Maintains patient/sponsor confidentiality; reports to work at designated times; maintains good attendance; follows up on issues; supports and adheres to organizational policies; accepts assignments and completes them timely; attends required meetings. Organizational Skills – Maintains organized files and office space; sets priorities effectively; demonstrates flexibility in schedule; submits routine reports on or before due date; maintains at‑a‑glance protocol information. Professional Growth and Professionalism – Demonstrates professionalism in appearance; seeks to increase skills through self‑directed learning; initiates new projects and contributions; takes continuing education; recognizes limitations and strives for improvement; acts as a team member both corporately and within the individual setting; preferred to obtain CCRP after two years of research experience. Certifications, Licenses, Education, and Experience Three (3) years of clinical research experience preferred. CCRP, CCRC, or equivalent preferred. Physical Requirements Must be able to lift up to 25 lb using regular office equipment and supplies. Might be required to help move study supplies to the research office. Requires extensive desk and computer use. Might have long periods of standing, walking, or sitting at a workstation. Work Environment Work environment characteristics are representative of those encountered while performing essential functions. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions. Use of radiation and hazardous chemicals: all employees are expected to foster a culture and environment of safety. Safety Sensitive: position is designated as safety sensitive under Arkansas code. Additional Requirements Resignation notice of a minimum of four (4) weeks is requested; resignations must be submitted in writing to the director and Human Resources. Benefits Highlands Oncology offers a full suite of benefits. #J-18808-Ljbffr Highlands Oncology Group