Research Regulatory Coord 1, Neurological Sciences
The Clinical Regulatory Coordinator I works under the general direction of the Research Administrator for the Section of Movement Disorders, and partnership with the Principal Investigator (PI), Co-Investigator(s), other study personnel, and sponsoring agents as well as with the Office of Research Affairs’ Clinical Research Administration Division, their Clinical Department / Division. The Research Regulatory Coordinator I serves as a contact within the Section between the Principal Investigator, study sponsor and the Rush Institutional Review Board. Research projects may involve multi-centered cooperative group studies, single site studies, intergroup studies, industry studies, and investigator initiated studies. The Research Regulatory Coordinator I conducts and/or prepares for internal and external regulatory reviews for clinical research. The individual who holds this position exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.
- Adheres to the policies, procedures, and guidelines instituted by Office of Research Affairs and the Office of Research Compliance.
- Works closely with the Clinical Research Administration Division to ensure Standard Operating Procedures (SOPs) are implemented and documented in accordance within study sponsor, Principal Investigator, and regulatory agency specifications.
- Serves as a regulatory contact for studies; ensures that regulatory compliance is met and that regulatory files are audit-ready.
- Determines and interprets applicable rules and regulations associated with complex clinical research studies and trials involving human subjects ensuring the protection of their safety, rights, and welfare.
- Works closely with the Section’s research administrator, study investigators, nurses, study coordinators, and study sponsors to coordinate study start-up activities, which involves collection and distribution of regulatory, and coverage analysis documents.
- Coordinates submissions to ancillary committees such as Protocol Review and Monitoring Committee, Radiation Safety Committee, and Institutional Biosafety Committee.
- Communicates with the IRB and study sponsor on behalf of the study team regarding regulatory management.
- Monitors email and to ensure that study documents are up to date and implemented in a timely fashion.
- Work along with Research Administrator to communicate with study team to ensure implementation of amendments, awareness of safety, and protocol changes and document version control. This includes attendance at research team meetings.
- Finalizes documents based on IRB comments and recommendations and ensures IRB approval of study.
- Reports regulatory activity to the study team at team meetings.
- Maintains accurate records related to all the regulatory research for Parkinson’s Disease and other Movement Disorder clinical trials.
- Assists Research Coordinators in developing Source Document templates for studies by completing comparison review of source document template against protocol schedule of activities and EDC snapshots. Helps to ensure that Source Documentation includes all data items required for all visits prior to enrollment of first subject and works with research coordinators to update Source Document template throughout the study.
- Conducts routine and ongoing review of research logs (including but not limited to: IP master inventory log, subject level IP logs, training logs, AE logs, conmed logs, delegation of responsibility logs, etc).
- Conducts weekly review of scheduled study visits, ensures data captured as the visits adheres to ALCOA practices, ensures data collected is entered into EDCs in timely manner.
- Proactively, conducts weekly review of data queries generated from data entry into EDC and reports information to Research Administrator. Works with Research Administrator and Research Coordinators to resolve queries in timely manner.
- Ensures timely reporting of Unanticipated Problems.
- Prepares regulatory files for audits and local monitoring visits.
- Updates databases for reporting requirements.
- Performs other duties as assigned.