UNIV - Research Regulatory Specialist - Hollings Cancer Center

Medical University of South Carolina

About The Position

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.

Requirements

A bachelor's degree and one year relevant program experience.

Responsibilities

Study Start-up Reporting and Activation Project Management
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).
Responsible for timely, accurate, input of required study start-up 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.
IRB Application and Document Management
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
Approval Processing and Quality Assurance
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 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 reviews and provides 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 an quality assurance deficiencies noted for regulatory documentation.
Regulatory Unit Support and Continuing Education
Participates in training curriculum and continuing education training 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 application university or HCC trainings.
Maintains effective relationships with sponsors/CROs