UNIV - Research Regulatory Specialist - Hollings Cancer Center

Job Description Summary

Under the general supervision of the Director, Hollings Cancer Center, Clinical Trials Office, this position provides functional direction, management, and supervision on a day-to-day basis to the Regulatory staff in the Clinical Trials Office. The role oversees regulatory activities for federal, corporate, and institutional research projects submitted and activated at the Hollings Cancer Center and promotes high-quality and efficient regulatory performance as required by the NCI Core Grant.

This position may be eligible for remote work after an orientation period.

• Oversees the study start-up process and manages the start-up timeline of all oncology clinical trials assigned within the respective Hollings Cancer Center Disease Focus Group(s) (DFG).
• Ensures timely, accurate input of required study startup milestones into the Clinical Trials Data System to facilitate efficient project management and metric tracking.
• Maintains OnCore per policy, updating study and personnel listings and task lists.
• Actively monitors start-up milestones across the HCC Clinical Trials Office (CTO), DFG, PRC, Institutional Review Board (IRB), and reports project updates to respective groups.
• Escalates any trials that exceed NCI CCSG metrics to the DFG leader and HCC CTO Unit managers.
• Interfaces with relevant MUSC, sponsor, and Clinical Research Organization (CRO) functional leads to prioritize essential document creation and meet task list deadlines.
• Completes the protocol submission form in the Protocol Review Committee (PRC) portal to initiate the scientific review process.
• Attends the CTO Pending Projects meetings and specific DFG meetings to provide input into prioritized tasks and follows up to ensure study start-up is compliant and timely.
• Effectively communicates regulatory requirements within project teams to assemble scope, timelines, and budgets.
• Provides DFG leaders with relevant data on time-to-activation metrics and assists the leader in identifying new trends and barriers.

• Prepares, submits, follows up, documents, and communicates all IRB submissions from initial application through termination, including amendments, reportable events, and annual renewals.
• Tracks IRB submissions using appropriate process task lists and enters accurate submission details and status updates in the clinical trials management system.
• Collaborates with sponsors/CROs to develop informed consent documents compliant with MUSC policies and verifies informed consent language with appropriate MUSC departments and ancillaries.
• Determines appropriate IRB of record and type of regulatory submissions or internal documentation required, and communicates study updates/IRB submission activity to the study team in a timely manner.
• Is proficient with IRB of record submissions for MUSC, WIRB, Advarra, NCI CIRB, and any other IRB of record for assigned studies.
• Prepares responses to IRB requests for information or study document revisions.
• Organizes all study documents per policies within hard copy and electronic systems, communicates updates, and releases IRB-approved documents to investigators, sponsors, ancillary teams, and CTO accurately and timely.

• Completes sponsor-required regulatory documentation as required and maintains accurate and comprehensive records in compliance with all applicable federal, state, and local regulations, policies, and Good Clinical Practice guidelines.
• Applies regulatory knowledge of federal regulation and standards, problem-solving, and continuous quality improvement methods in daily operations.
• Creates and maintains essential regulatory documents.
• May travel to campus to meet with investigators and staff to obtain signatures for regulatory documents.
• Maintains accurate and complete hard copy study files.
• Assists with sponsor and internal monitoring visits and reviews, providing regulatory support to meet the needs of monitors and auditors during site visits.
• Addresses and reports to the IRB any regulatory findings or follow-up items noted by the site…