Senior Regulatory Coordinator
Under the guidance of the Principal Investigator and in conjunction with the Clinical Research Nurse, the Senior Regulatory Coordinator is responsible for assuring the integrity and quality of the Clinical Research Trial is maintained and the Trial is conducted in accordance with good Clinical Practice guidelines, Federal and Sponsor regulations, and Loyola University Policies and Procedures.
Minimum Education and/or Work Experience
Required
- Bachelor’s Degree
- 3 – 5 years of Clinical Trials Regulatory experience is required.
Preferred
- Master’s Degree in Regulatory Affairs.
- Experience in working with the Oncology population.
Stays current with Federal regulations and can apply knowledge to work related activities. Has working knowledge of regulations pertaining to retention of records, protection of human subjects, IRB, FDA, and other regulations governing clinical research.
- Communicates with the CCTO Study Teams and Disease programs distributing new NCTN Study activations, closures, termination, amendments and safety reports, etc.
- Submits new Study projects to the local IRB, Central IRBs including- Cancer Trials Support Unit (CTSU), National Marrow Donor Program (NMDP) and Central Institutional Review Board (CIRB).
- Completes and tracks IRB submissions including amendments, serious adverse events, closures, and annual reviews for local and central IRBs.
- Continually communicates with CTSU/NMPD/CIRB Coordinators to ensure all amendments are submitted within a timely manner to central IRB and the local IRB.
- Completes Principal Investigator worksheets in the CIRB manager IRB portal annually or as needed in order for PIs to maintain their eligibility to implement protocols within Loyola.
- Assists investigators in submitting emergency use Drug Applications as necessary and submits documents to FDA for annual review/as needed.
- Works closely with the Study Staff to schedule site initiation visits, monitoring visits, and close out visits.
- Works with the Contract Research Organizations and monitors for Study related management expectations and ensure regulatory compliance.
- Communicates with the local IRB to ensure all boilerplate templates for central IRBs align with regulations and local IRB standards.
- Maintains regulatory documents, (including 1572s, Delegation of Authority logs, Financial Disclosure Forms, Consent Forms, and trainings) for pharmaceutical/CIRB and/or cooperative group protocols and ensures the Study Team and Investigators have completed the required training.
- Trains/assists new/seasoned Staff on regulatory process including CITI training, Study start-up, IRB submissions, maintaining a Study, and ensuring all essential documents are correct to submit to monitor/sponsor.
- Assists Staff in archiving Study files and ensures all Staff have appropriate box # to archive Studies, assists with boxing any regulatory files or patients charts in appropriate boxes, maintains a catalog of all Studies archive, and ensures all files are kept in a secure place.
- Coordinates regulatory agenda with regulatory coordinators/Leads weekly regulatory meetings.
- Meets with Principal Investigators to review all active, closed, and upcoming Studies and attends Research meetings with the multidisciplinary Teams.
- Coordinates meetings with the Study teams (Research Nurses and CRCs) weekly to review regulatory status of Studies.
- Assists investigators with CITI training and renewing their Cancer Therapy Evaluation Program (CTEP) number for the NCI Clinical Trials in the Registration and Credential Repository (RCR).
- Participates in internal/external audits to ensure regulatory compliance and implement corrective and preventive action plans as needed.
- Maintains CCCTO website with protocol, consents, and accurate status of (closed, temp closed, or pending).
- Maintains master tracker with other regulatory coordinators for Study statuses.
- Utilizes Docusign for Study needs as appropriate.
- Performs other duties as assigned.