Research Regulatory Specialist-Department of Neurosurgery

• 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 noncompliance 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 reapprovals or IRB expirations.
• Maintains uptodate 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 protocolspecific 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 reconsent requirements; ensures completion and proper documentation of updated trainings
• Collaborates with Principal Investigators Clinical Research Coordinators and others for submission of reportable events work with Principal Investigators Clinical Research Coordinators and other necessary parties to draft submit and implement Corrective Action Preventive Action (CAPA) plans. Assist with trial audits for continued compliance with approved CAPA.

Continuing Review & Study Closure

• Independently completes continuing review/study closure report forms and attaches supporting documentation such as cumulative adverse event tables deidentified signed informed consent documents subject enrollment status Data Safety Monitoring Board reports and/or audit reports
• Reviews documents with Principal Investigators Clinic Staff and/or Program Assistants for accuracy noting inconsistencies and inaccuracies as necessary to be corrected within documents or the CTMS
• Submits documents to IRBs within appropriate timelines to prevent project expiration or sponsor deficiencies tracking progress and addressing IRB inquiries as requested
• Audits approved documents to detect inaccuracies
• Updates study data and materials filing approval documents in regulatory and/or study binders distributing new documents to all pertinent parties.

For consideration please complete an application and include a cover letter resume and the names and email addresses of three to five references.

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To claim veterans preference indicate the claim on the application and provide required documentation by uploading a DD214 (or equivalent certification from the Department of Veteran Affairs) and any additional supporting documentation based on the type of claim.