INACTIVE
Full-Time
Univ – Research Regulatory Specialist
Hollings Cancer Center
Posted on 2/21/2026
Medical University of South Carolina
No salary listed
Charleston, SC, USA
In Person
Category
 Legal & Compliance (1) |
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Required Skills
Ruby
Requirements
- A bachelor's degree and two years of relevant program experience.
Responsibilities
- Oversee the study start-up process and manage the start-up timeline of all oncology clinical trials assigned within the Hollings Cancer Center Disease Focus Group(s), aiming for average time to activation of 90 calendar days from Protocol Review Committee submission.
- Input required study start-up milestones into the Clinical Trials Data System to facilitate project management and metric tracking.
- Maintain OnCore per policy, updating study and personnel listings and task lists.
- Monitor start-up milestones across the Hollings Cancer Center Clinical Trials Office, Disease Focus Group, Protocol Review Committee, Institutional Review Board, and report project updates to respective groups.
- Escalate any trials that exceed National Cancer Institute Cancer Center Support Grant metrics to the Disease Focus Group leader and HCC Clinical Trials Office Unit managers.
- Interface with MUSC, sponsor, and Clinical Research Organization functional leads to prioritize essential document creation to facilitate synchronized start-up and meet task list deadlines.
- Complete the protocol submission form in the Protocol Review Committee portal to initiate the scientific review process.
- Attend the CTO Pending Projects meetings and Disease Focus Group meetings to provide input into prioritized tasks and follow up to ensure start-up of studies in a compliant and timely manner.
- Effectively communicate regulatory requirements within project teams so that scope, timelines and budgets can be assembled accordingly.
- Provide Disease Focus Group leaders relevant data on time to activation metrics and assist the leader in identifying new trends and barriers.
- Prepare, submit, follow up on outcomes, and communicate all IRB submissions from initial application through termination, including amendments, reportable events, and annual renewals.
- Track IRB submissions using process task lists and enter accurate submission details and status in the clinical trials management system.
- Collaborate with sponsors/Contract Research Organizations to develop informed consent documents compliant with MUSC policies and verify consent language with appropriate MUSC departments.
- Determine the appropriate IRB of record and type of regulatory submissions required, and communicate study updates/IRB submission activity to the study team.
- Be proficient with IRB of record submissions for MUSC, Western Institutional Review Board, Advarra, National Cancer Institute Central IRB, and other IRBs.
- Prepare responses to IRB requests for information or study document revisions.
- Organize all study documents per policies in hard copy and electronic systems; communicate updates and release IRB approved documents to investigators, sponsors, ancillary teams, and CTO accurately and timely.
- Complete sponsor-required regulatory documentation as required, and maintain accurate and comprehensive documentation as required by the sponsor in compliance with all applicable federal, state and local regulations, policies and procedures and Good Clinical Practice guidelines.
- Apply regulatory knowledge of federal regulation and standards, problem solving and continuous quality improvement methods in daily operations.
- Create and maintain essential regulatory documents.
- May go on campus to meet with investigators and staff to obtain signatures for regulatory documents.
- Maintain accurate and complete hard copy study files.
- Assist with sponsor and internal monitoring visits and provide regulatory support to effectively meet the needs of monitors and auditors during site visits.
- Address and report to the IRB any regulatory findings or follow-up items noted by the site monitor/auditor. Promptly reviews and addresses quality assurance deficiencies noted for regulatory documentation.
- Participates in training curriculum and continuing education of employees.
- Participates in Regulatory coverage plans as needed.
- Works effectively and cooperatively with others in achieving organizational goals; maintains harmonious working relationships with fellow employees. Applies MUSC Standards of Behavior to all aspects the job assigned.
- Participates in monthly regulatory meetings and other HCC CTO staff meetings and university or HCC trainings.
- Maintains effective relationships with sponsors/CROs.
INACTIVE