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Sr Research Protocol Analyst

City of Hope

City of Hope

IT
Posted on Saturday, July 6, 2024

SR. RESEARCH PROTOCOL ANALYST-REMOTE

Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today.

Basic and Translational Research Protections (BTRP) provides administrative, regulatory and operational support to the Biospecimen and Data Research Oversight Committee (BDROC), a committee that supports the regulatory and operational functions of City of Hope’s system biobanking efforts and its corresponding research. Senior Research Protocol Analysts also manage a portfolio of research protocols that require oversight of the BDROC. Senior Research Protocol Analysts are subject matter experts in the NCI Cancer Center Support Grant (CCSG) requirements, specifically the Scientific Review aspects as part of the Protocol Review and Monitoring System and the necessary reporting requirements for Data Table 4 applicable studies. Senior Research Protocol Analysts serve as the primary point of contact for issue resolution with Principal Investigators (PIs), study team members, committee members, and other departments involved in the review, approval and oversight of research conducted at City of Hope facilities or by its employees or agents. Senior Research Protocol Analysts also support the department leadership in program evaluation and project management, including for BDROC and banking activities within the COH network.

As a successful candidate, you will:

Protocol Management:

  • Shepherd protocols through BDROC review process for timely compliance.
  • Conduct pre-reviews to ensure submission completeness and compliance with institutional requirements.
  • Monitor and ensure timely review by committee/expedited reviewers.
  • Prepare comprehensive meeting minutes and action notices for investigators.

Committee Meetings:

  • Prepare materials for committee meetings, focusing on assigned protocol submissions.
  • Provide guidance and references for novel submissions to committee members.
  • Address committee inquiries during meetings based on protocol history and determinations.

Internal and External Audits:

  • Act as primary contact for preparing audit materials and ensuring protocols are audit-ready.
  • Maintain compliance with internal and external audit requirements through current and complete documentation.

Quality and Compliance Initiatives:

  • Identify opportunities for process improvement and efficiency to enhance regulatory compliance.
  • Stay updated on regulations, assist in training staff on regulatory impacts, and participate in quality improvement projects.
  • Support departmental initiatives such as policy development, electronic form revisions, workflow updates, and educational sessions.

Qualifications

  • Bachelor’s degree
  • Experience may substitute for minimum education requirements
  • At least 5 years of experience in the academic/clinical research review setting

City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here.

To learn more about our Comprehensive Benefits, please CLICK HERE