Research Regulatory Specialist-Department of Neurosurgery

Classification Title:

Research Regulatory Specialist

Classification Minimum Requirements:

Bachelor’s degree and two years of relevant experience, or an equivalent combination of education and experience

Job Description:

Portfolio Management

• Responsible for understanding and interpreting the Code of Federal Regulations, Institutional Review Board policies and procedures as well as other regulatory policies  regarding human subject research. 
• Reviews proposed protocols and determines appropriate regulatory agency for submission, instructing PIs, research team, auditors, and other affiliated staff on the required process, providing direction and guidance regarding the procedure and required forms and documentation necessary for compliance. 
• Maintains knowledge of site and sponsor specific requirements as well as ensuring compliance for all assigned studies that are active or pending. 
• Assists with review of source and regulatory documents to address sponsor/auditor queries, conduct regulatory binder reviews to ensure completeness, and be able to identify required ancillary office reviews for specific scenarios and/or trials. 
• Audits assigned trials for regulatory compliance, identifying non-compliance and directing assigned study staff to make required corrections. 
• Responsible for promoting Human Subjects Protections within study sites for assigned trials and supporting the safety of clinical research patients/research participants, ensuring compliance by study staff, research teams, PIs, clinic staff, etc. assigned to and/or working on their trials.
• Reviews CTSU website for NCTN trial updates relayed through trial specific broadcasts or dashboards. 
• Collaborates with regulatory agencies as well as PIs, clinical or research staff, and ancillary offices to ensure requirements related to updated findings are completed within the required timeframe. 
• Independently initiates all required Institutional Review Board (IRB) submissions and entries into CTMS (OnCore) system. 
• Responsible for maintaining and updating CTMS with all IRB approvals. 
• Performs quality assurance reviews of the tracking database to prevent deficiencies related to delayed re-approvals or IRB expirations. 
• Maintains up-to-date comprehensive regulatory and/or study binders. 
• Attend meetings with PI, research team, sponsors, auditors or other affiliated staff as necessary. 
• Participates in SQV, SIV, monitoring, and close out visits as required per sponsor, Principal Investigator or regulatory agency. 

 

 Initial Study Submission & Activation

• Responsible for the coordination and management of all new study submissions made to assigned IRBs and regulatory agencies for new and proposed research within their portfolio  Additionally, incumbent will direct the submission process, providing guidance on the necessary processes, documentation, format, etc. to sponsors, study team, research administrators, and/or PI(s).
• Reviews study protocols, collaborating with study sponsors, study team, research administrators, and PI(s) as necessary to obtain and provide all relevant data necessary for IRB submission
• Submits new projects, either local or ceded reviews, to assigned IRBs and regulatory agencies
• Tracks submissions while shepherding trials through the approval process, attending all meetings related to submitted trials as the regulatory authority conducts their review and provides further information to address any identified reviewer concerns
• Audits approval documents for inaccuracies, obtaining the necessary changes prior to study activation
• Enters complete study approval information into OnCore CTMS database

Study Maintenance & Upkeep

• Routinely reviews clinical research regulatory websites (including PBTC, PNOC, ALLIANCE, CTSU, COG, SWOG, NRG Oncology, etc.) for protocol-specific updates
• Coordinates study revisions, reviewing addenda to determine appropriate reporting requirements and reporting timeframes, independently and accurately preparing IRB submission packets including changes to informed consent documents, and reviewing submission packets with Principal Investigators, Study Coordinators, Clinical Research Assistants, and/or sponsors for accuracy
• Reports serious adverse events, IND reports, protocol addenda and/or other documents to Institutional Review Boards as identified by study team
• Manages revision approval process, tracking submissions and addressing any IRB inquiries as necessary to maintain compliance
• Reviews approved documents for inaccuracies, requesting and obtaining necessary changes
• Update CTMS and alert study team and ancillary staff of new documents and/or patient reco