UNIV - Regulatory Post-Activation Coordinator - Hollings Cancer Center

Responsibilities

• Regulatory submissions for reportable events, continuing renewals and local changes
• Prepares submissions through IRB approval of continuing renewals, reportable events (Protocol Deviations, Internal Serious Adverse Events, External Serious Adverse Events) and locally generated amendments such as study staff or investigator changes from the point of study activation until study termination.
• Tracks IRB applications within OnCore by releasing and updating task lists.
• Utilizes OnCore forms and reports to accurately track expirations dates and make continuing renewal submissions.
• Utilizes the CTO internal forms for reportable events, personnel and investigator changes to initiate new task lists in OnCore and initiate IRB applications.
• Prepares study-specific personnel credentialing documents such as delegation logs and protocol training documents and updates.
• Maintain OnCore per policy, updates study and personnel listings, SPARC personnel lists, and eReg.
• Is proficient with IRB of record submissions for MUSC, WIRB, Advarra, NCI CIRB, and any other IRB of record for studies assigned.
• Effectively communicates regulatory requirements within project teams and consistently enters status changes and personnel updates within 24 hours within application systems such as OnCore, eReg, SPARC and other systems.

Document Management and Quality Assurance

• Conducts internal quality assurance checks in preparation of external monitor visits or sponsor/FDA audits.
• Affirms that all study documents are filed and labeled appropriately per Good Clinical Practice Guidelines.
• Receives and reviews internal monitor visit letters.
• Filings the correspondence and works with the study team to address all issues prior to the monitor/audit visit.
• This may include reaching out to the study and data coordinators to verify that their clinical operation findings are addressed prior to the next visit.
• May provide assistance or coverage to the Pre-activation and amendment processing regulatory specialist as needed, particularly in the maintenance of the trial master file and accurate posting of study documents for the release to the team and preparation of the monitor or audit visit.
• Supports the transition of trial documents from hard copy to electronic within eReg software.
• Ensures that the transition of documents is completed per policy.

Monitor Visit Scheduling and Attendance/Support

• For studies assigned within the CTO team, this role is responsible for the scheduling of monitor visits on behalf of the study team.
• This includes scheduling time for the regulatory, study coordination/clinical operations review and time with PI and ancillary services such as investigational drug services.
• Utilizes the Study Monitor Visit request form for tracking monitor visit requests and status.
• Communicates in a professional, timely and accurate manner to the sponsor, PI, ancillary services and study team.
• This will include the creation of study visit confirmations and agendas along with support documents to sponsor visitors about system access instructions and directions.
• Supports the request to EPIC and initiates monitor reviews within eReg.
• Filings all monitor visit documentation within the trial master file.
• This includes correspondence, agendas, sponsor letters, and site visit logs.
• Reviews the prior monitor visit letters prior to the next visit to ensure that findings are addressed and appropriately in process.

Regulatory Unit Support and Continuing Education

• May support data entry and reporting of quality assurance findings and participate in process improvement projects.
• Participates in training curriculum and continuing education training of employees.
• May help with training, mentorship, and process improvement projects.
• Participates in Regulatory unit 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.