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Full-Time

Univ – Research Phase I Regulatory Specialist

Hollings Cancer Center

Posted on 11/21/2024

Medical University of South Carolina

Medical University of South Carolina

Compensation Overview

$39k - $72.1kAnnually

Mid

Charlotte, NC, USA

Category
Legal
Risk & Compliance
Legal & Compliance
Requirements
  • A bachelor's degree and three years of relevant program experience.
Responsibilities
  • Helps to oversee the study start-up process and manages the start-up timeline of all Phase 1 solid tumor and fast track oncology clinical trials assigned within the respective Hollings Cancer Center Disease Focus Group(s) (DFG).
  • Responsible for timely, accurate, input of required study start-up milestones into the Clinical Trials Data System to facilitate efficient project management and metric tracking.
  • Maintain OnCore per policy, updating study and personnel listings and task lists.
  • Actively monitors start-up milestones across the HCC Clinical Trials Office (CTO), DFG and PRC, Institutional Review Board (IRB) and reports project updates to respective groups.
  • Any trials that exceed NCI CCSG metrics will be properly escalated to the DFG leader and HCC CTO Unit managers.
  • Interfaces with relevant MUSC, sponsor, and Clinical Research Organization (CRO) functional leads to ensure appropriate prioritization of essential document creation to facilitate synchronized start-up and ensure task list deadlines are met.
  • Completes the protocol submission form in the Protocol Review Committee (PRC) portal to initiate the scientific review process.
  • Attends the CTO Pending Projects meetings and specific DFG meetings to provide input into prioritized tasks and follows-up to ensure start-up of studies in a compliant and timely manner.
  • Effectively communicates regulatory requirements within project teams so that scope, timelines and budgets can be assembled accordingly.
  • Provides DFG leaders relevant data on time to activation metrics and assists the leader in identifying new trends and barriers.
  • Responsible for preparation, submission, outcome follow-up, documentation and communication of all IRB submissions from initial application through termination.
  • Efficiently tracks IRB submissions by utilizing the appropriate process task lists and entering accurate submission details and status updates in the clinical trials management system.
  • Collaborates with sponsors/CROs to develop informed consent documents that are compliant with MUSC policies and verifies informed consent language is accurate with appropriate MUSC departments and ancillaries.
  • Determine appropriate IRB of record and type of regulatory submissions or internal documentation that are required and communicate study updates/IRB submission activity to the study team in a timely manner.
  • Is proficient with IRB of record submissions for MUSC, WIRB, Advarra, NCI CIRB, and any other IRB of record for studies assigned.
  • Prepare responses to IRB requests for information or study document revisions.
  • Organizes all study documents per policies within hard copy and electronic systems.
  • Communicates updates and releases IRB approved documents to investigators, sponsors, ancillary teams, and CTO accurately and timely.
  • Complete sponsor required regulatory documentation as required.
  • Initiate and maintain accurate and comprehensive documentation as required by the sponsor in compliance with all applicable federal, state and local regulations, policies and procedures and Good Clinical Practice guidelines.
  • Effectively applies regulatory knowledge of federal regulation and standards, problem solving and continuous quality improvement methods in daily operations.
  • Create and maintain essential regulatory documents.
  • May go on campus to meet with investigators and staff to obtain signatures for regulatory documents.
  • Maintain accurate and complete hard copy study files.
  • Assist with sponsor and internal monitoring visits and reviews and provides regulatory support to effectively meet the needs of monitors and auditors during site visits.
  • Address and report to the IRB any regulatory findings or follow-up items noted by the site monitor/auditor.
  • Promptly reviews and addresses an quality assurance deficiencies noted for regulatory documentation.
  • Participates in training curriculum and continuing education.
  • Participates in Regulatory 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.
Medical University of South Carolina

Medical University of South Carolina

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