Program Manager I, Protocol Review & Monitoring System Tisch Cancer Institute

The Program Manager I (PM)is responsible for providing administrative operational and programmatic oversight of the Protocol Review and Monitoring System. The PM is responsible for all ensuring that all cancer-related clinical research receives appropriate peer-review prior to activation and then regular monitoring for scientific progress.

The Program Manager will have a thorough knowledge of institutional PRMC policies and procedures and National Cancer Institute (NCI) guidelines related to cancer clinical trials. The PM coordinates all activities of the scientific committees (disease focus groups protocol review and monitoring committees) including scheduling meetings preparing agendas and meeting materials and documenting minutes. The PM manages the intake process and all correspondences with Principal Investigators regarding protocol approvals amendments and stipulations. The PM execute decisions regarding expedited approval and studies needing administrative approval. The PM facilitates compliant documentation and capture of clinical trials data within our clinical trials management system (OnCore).

The PM is instrumental in developing program policies procedures workflows and tools that promote operational efficiency and is responsible for producing routine metric reports for leadership evaluation. The PM is accountable to the PRMS Chairs PRMS Director and reports to the Executive Director Enterprise Cancer Clinical Research.

• Ensure the smooth operation and regulatory compliance of Protocol Review and Monitoring Committee (PRMC) and Disease Focus Group (DFG) meetings in alignment with NCI guidelines and institutional charters (or equivalent):
  • Coordinate all aspects of committee meetings including agenda preparation meeting materials meeting minutes attendance logs document decisions timely dissemination of materials reviewer assignments attendance tracking minute-taking meeting facilitation and preserving the integrity of the voting processes.
  • Oversee the PRMS intake process by screening protocol submissions for completeness and accuracy confirming all required documents and information are present before committee review and coordinating with investigators or study teams to resolve discrepancies or deficiencies. Ensures timely resolution of issues to allow protocols to move swiftly through the pre-review process.
  • Maintain proactive communication with the committee chair reviewers and DFG/PRMC members to coordinate assignments clarify expectations and ensure timely completion of reviews voting and decision-making in alignment with committee procedures and review timelines. Follows up on outstanding items through resolution.
  • Coordinate Corrective Action Plan reviews with DFG Chairs when required by PRMC. Work with PI research team and DFG members to develop action plans to increase accrual on low accruing studies; monitor screen failure rates as requested and report back to DFG.
  • Promptly identifies and corrects issues or deficiencies to minimize committee disruptions and/or delays.
• Lead quality assurance activities across the PRMS to ensure accurate documentation scientific rigor and NCI-designated cancer center compliance.
  • Responsible for validating key fields required for NCI reporting and TCI leadership reporting (i.e. risk classification rare cancer designation sponsor type protocol primary purpose target annual accrual. Periodically audits data entries in OnCore and PRMS databases to confirm accuracy and consistency with meeting outcomes and institutional policies.
  • Perform quality checks of DFG and PRMC review documentation including decision trees priority scores review forms meeting minutes and corrective action plans to ensure data completeness and process fidelity.
  • Maintain accurate centralized records of committee decisions protocol status and meeting materials using standardized templates and organized trackers to support reporting audit readiness and operational transparency.
• Coordinate and manage all communication streams related to the PRMS to ensure transparency alignment and timely dissemination of information across TCI
  • Serves as the primary point of contact for committee chairs members research community investigators and TCI leadership responding to inquiries and facilitating issue resolution.
  • Draft distribute and track outcome letters and formal committee communications to investigators/study teams ensuring clarity of review outcomes required revisions and next steps; coordinate messaging between PRMC DFG/MFG FFR IRB and DSMC as appropriate.
  • Establish and maintain consistent communication with ancillary offices such as the IRB Clinical Research Support Unit (CRSU) and Financial Feasibility Review (FFR) and Community Outreach and Engagement (COE) to align processes reduce delays and support operational efficiency.
  • Prepare institutional memos and deliver presentations to the research community about relevant committee functions and changes.
  • In conjunction with committee Chairs develop high-quality content and ensure timely delivery of relevant informationincluding biannual performance reports trend summaries and issue escalation updatesto the Clinical Research Steering Committee (CRSC) enabling informed oversight and institutional accountability.
• Execute administrative functions of the PRMS
  • Conduct administrative review and approval of protocols that do not require full board review including determination and issuance of waivers exemptions and other independent review decisions; consult with chairs as needed to ensure appropriate adjudication and documentation.
  • Provide interpretation of committee policies and offer guidance to investigators study teams and chairs on process navigation potential resolution pathways and appropriate tactical routes for protocol progression.
  • Support committee membership management including rosters onboarding term tracking monitoring of good standing and presentation of new member nominations to leadership.
  • Maintain confidentiality in all committee proceedings and communications.
  • Coordinate honorarium payments CME activities and conflicts of interests related to the PRMS.
  • Fulfill obligations as an ancillary reviewer in the IRB system (RUTH) timely.
• Design deliver and manage comprehensive training and education strategies to ensure consistent understanding adherence and effective participation in PRMS processes across Tisch Cancer Institute.
  • Serves as a subject matter expert with comprehensive knowledge of PRMS policies and procedures providing guidance and promptly addressing inquiries from committee members investigators and research staff accurately consistently and completely.
  • Coordinates PRMS member orientation including member orientation video meet with the new member to formally review policies and procedures and software systems arrange meeting observations review responsibilities and assigns a mentor as applicable.
  • Assesses training needs across PRMS members chairs investigators study teams and research units (e.g. regulatory affairs) and develops targeted educational content and strategies to address identified knowledge or process gaps.
  • Delivers basic education and training at new employee orientation organizes and delivers bootcamps or equivalent workshops.
  • Promotes policy adherence by educating the research community and committee members on review responsibilities facilitating timely scientific review and re-review of cancer clinical trials and guiding appropriate triage through established review pathways.
• Ensure accurate complete and accessible documentation across PRMS systems to support regulatory compliance data integrity and operational efficiency.
  • Implement and maintain logical user-friendly electronic storage mechanisms with standardized naming conventions folder structures and version control to facilitate easy access and long-term traceability.
  • Develop and manage clear concise tracking tools with appropriate labels legends and definitions to support transparency progress monitoring and audit readiness.
  • Maintain accurate and complete records in OnCore and ensure information in the IRB system is quality-checked verified and corrected as needed to reflect current protocol status classifications and review type (i.e. concurrent) and outcomes.
  • Maintain accurate documentation and data integrity in clinical trial management systems (e.g. OnCore) and monitor review timelines and protocol progress (i.e. dashboards) to support NCI-mandated tracking and reporting.
  • Maintain and update Charter user manuals and PRMS operating manual (or equivalent) to ensure standard operating practices across the health system.
• In conjunction with the Executive Director of Systems and Data manage and present accurate timely and actionable reports to support oversight strategic planning and compliance for the PRMS.
  • Prepare and present metrics and analytic summaries to the Chairs CRSC Cancer Center leadership
  • Prepares reliable and accurate program data for routine meetings.
  • Monitor dashboards and review timelines to ensure timely PRMS review and re-review of protocols proactively identifying delays or process gaps for resolution.
  • Produces high-quality validated data and ad-hoc reports for TCI external advisory board (EAB) and NCI required reporting. Participates in the preparation of the grant progress reports and renewal application.
• Process improvement
  • Monitor dashboard and other reports to identify enhancement areas and presents new ideas to leadership.
  • Updates to forms and software systems in conjunction and with approval by the Exec director data management
• Lead and support continuous process improvement initiatives to optimize PRMS efficiency compliance and stakeholder experience.
  • Identify and analyze workflow inefficiencies recurring bottlenecks or deviations from review timelines and propose solutions to streamline operations.
  • Collaborate with committee members study teams and research units to pilot refine and implement enhancements to PRMS policies tools procedures and technical systems.
  • Monitor and evaluate the impact of implemented changes using key metrics and stakeholder feedback to ensure sustained improvements and alignment with NCI expectations and institutional goals.
• Maintains liaison with staff in other departments to coordinate program activities and training; to accomplish program objectives; and to ensure cooperative efforts are enhanced and available resources are utilized.
• Administers program procedures and systems. Ensures information is disseminated to research community regarding PRMS.
• Confers with and advises staff and others to provide technical advice problem solving assistance answers to questions and program goals and policy interpretations; refers to appropriate department or person when unable to respond.
• Develops and independently implements new or revised program goals strategies and objectives to sustain and grow programs and services.
• May perform needs assessment analyzes and report results for basis of program development or quality improvement.
• Oversees and manages the activities of subordinates and consultants and provides leadership and direction for staff if applicable setting an effective agenda to ensure that performance goals are met.
• Performs other related duties.
  

• Bachelors degree or greater preferred or a combination of applicable experience and education
• 3 years experience (5 preferred) managing and administrating program activities for assigned area
• Preferred qualifications:
  • Excellent written and oral communication skills
  • Excellent organizational skills and the ability to prioritize multiple tasks projects and assignments
  • Exceptional attention to detail and accuracy