UNIV - Research Regulatory Specialist - Hollings Cancer Center

Job Description Summary

Under the general supervision of the Director, Hollings Cancer Center, Clinical Trials Office, provides functional direction, management, and supervision on a day-to-day basis to the Regulatory staff in the Clinical Trials Office. Oversees the 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.

Medical University of South Carolina (MUSC - Univ)

Employee

Classified

CC001332 HCC CTO Administration

Hourly

University-05

$39,764.00 - $56,670.00 - $73,576.000

40

Under the general supervision of the Director, Hollings Cancer Center, Clinical Trials Office, provides functional direction, management, and supervision on a day-to-day basis to the Regulatory staff in the Clinical Trials Office. Oversees the 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.

Helps to oversee 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). As outlined within the NCI Cancer Center Support Grant, the aim for the average time to activation is 90 calendar days from the time of Protocol Review Committee (PRC) submission.

• Responsible for timely, accurate input of required study startup milestones into the Clinical Trials Data System to facilitate efficient project management and metric tracking.
• Maintain OnCore per policy, updating study and personnel listings and task lists.
• Actively monitors start-up milestones across the HCC Clinical Trials Office (CTO), DFG and PRC, Institutional Review Board (IRB) and reports project updates to respective groups. Any trials that exceed NCI CCSG metrics will be properly escalated to the DFG leader and HCC CTO Unit managers.
• Interfaces with relevant MUSC, sponsor, and Clinical Research Organization (CRO) functional leads to ensure appropriate prioritization of essential document creation to facilitate synchronized start-up and ensure task list deadlines are met.
• 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 start-up of studies in a compliant and timely manner.
• Effectively communicates regulatory requirements within project teams so that scope, timelines and budgets can be assembled accordingly.
• Provides DFG leaders relevant data on time to activation metrics and assists the leader in identifying new trends and barriers.

• Responsible for preparation, submission, outcome follow-up, documentation and communication of all IRB submissions from initial application through termination. This includes amendments, reportable events, and annual renewals. Communicate the study status updates and ensures that the study team has valid study documents to complete tasks. This responsibility commences at the original point of project entry and continues through IRB termination of projects.
• Efficiently tracks IRB submissions by utilizing the appropriate process task lists and entering accurate submission details and status updates in the clinical trials management system.
• Collaborates with sponsors/CROs to develop informed consent documents that are compliant with MUSC policies and verifies informed consent language is accurate with appropriate MUSC departments and ancillaries.
• Determine appropriate IRB of record and type of regulatory submissions or internal documentation that are required and communicate 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 studies assigned.
• Prepare 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.

• Complete sponsor required regulatory documentation as required. Initiate 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.
• Effectively applies…