Sr Research Protocol Analyst

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary

This position provides administrative, regulatory and scientific support to several of the institutional research oversight committees. Portfolio consists mainly of Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), and Radiation Safety Committee (RSC) protocols, and to a lesser extent, Stem Cell Research Oversight (SCRO) Committee protocols. The Senior Research Protocol Analyst also provides administrative and operational support for the Dual Use Research of Concern (DURC) Institutional Review Entity (IRE). The Senior Research Protocol Analyst will be involved in drafting institutional policies to address federal and state requirements regarding animal welfare; use of recombinant and synthetic nucleic acids, biohazardous materials, hazardous chemicals, and physical hazards; use of radioactive materials and radiation producing machines; and use of pluripotent stem cells. This position involves frequent communication with research investigators and their staff to facilitate protocol submission and review processes, requiring an understanding of the proposed projects and scientific approaches. The Senior Research Protocol Analyst participates in a team effort to coordinate generation and distribution of meeting agendas and materials for review and develops meeting minutes reflective of the committee's protocol review activity, deliberations and decision-making. The position assists with all aspects of committee member management, including new member onboarding and training, continuing education, and communication regarding committee member review assignments. This position works closely with the Center for Comparative Medicine and Occupational Safety and Health to ensure all regulatory requirements related to the committees are being met.

Key Responsibilities include:

. Provide administrative, regulatory and scientific support and guidance to the committees.

• Oversee entry and tracking of protocol submissions and review process within the iRIS database
• Ensure pre-reviews are being performed
• Assign review path and reviewers appropriately to meet regulatory requirements
• Assist Principal Investigators and their research teams in drafting new protocols, amendments and renewal submissions
• Serve as a resource for investigators for all committees
• Schedule and coordinate committee meetings and ensure quorum is met
• Ensure agendas for committee meetings are complete and circulated
• Draft highly technical meeting minutes that are reflective of the committee's protocol review activity, deliberations and decision-making
• Communicate committee decisions to investigators and assist with addressing responses to committee requests for modifications
• Ensure coordination and communication between the relevant committees
• Draft and maintain updated SOPs, workflows and policies
• Assist with recruiting and onboarding new committee members

In depth review as required

• Engage in a substantive pre-review of protocol submissions, ensuring all relevant sections and fields of a submission are complete and consistent from a scientific and regulatory perspective; protocol complies with all regulations and policies; protocol is written artfully to minimize future amendments; and relevant ancillary committee approvals are in place.
• Work constructively with investigators to revise protocols, as needed, to bring protocols into compliance with regulatory requirements and City of Hope policies and procedures prior to distributing to committee members for review. Consult with the LRP Director/committee chairs/veterinarians/safety staff as needed to ensure accuracy of pre-review in complex cases.
• Work extensively with new investigators prior to or upon arrival at City of Hope to establish their protocols.

Supporting the Director

• Maintain registrations with federal agencies for the IACUC, IBC, and SCRO.
• Coordinate external and internal audits of the committees and assist the LRP Director with addressing any findings.
• Schedule and plan the semi-annual research facilities inspections program (IACUC). Communicate with Center for Comparative Medicine and investigators regarding IACUC inspections to ensure that follow-up items and findings are documented and appropriately addressed according to deadlines.
• Compile and finalize extensive semi-annual reports which are submitted to the Institutional Official (IACUC).
• Conduct congruence analysis to ensure that proposed animal activities are consistent with the associated funding application(s).
• Assist with administrative duties related to investigating noncompliance events and drafting reports to regulatory agencies, including coordinating review and approval by key parties.
• Compile metrics/reports to identify opportunities for improvement, making recommendations to the LRP Director and Research Operations Leadership.
• Oversee website maintenance, ensuring all links and documents are updated and working
• Perform quality control and process improvement activities, as required.
• Liaise with regulatory agencies and professional organizations, as needed.

Basic education, experience and skills required for consideration:

• Bachelor's degree in a related science field
• Experience may substitute for minimum education requirements

• Minimum 5-8 years relevant work experience required

Required Certification/Licensure:

Preferred education experience and skills:

• Master's degree in a related science field

• Experience with IACUC, IBC and/or RSC committee functions, as well as SCRO and Occupational Safety procedures.

Additional Information:

• To protect the health of patients and staff and to comply with new State of California mandates, City of Hope staff are required to show proof of full vaccination by September 30, 2021. Compliance is a condition of employment.
  
  Basic education, experience and skills required for consideration:
  
  • Bachelor's degree in a related science field
  • Experience may substitute for minimum education requirements
  • Minimum 5-8 years relevant work experience required
  
  
  Required Certification/Licensure:
  
  Preferred education experience and skills:
  
  • Master's degree in a related science field
  
  
  
  • Experience with IACUC, IBC and/or RSC committee functions, as well as SCRO and Occupational Safety procedures.
  
  
  Additional Information:
• To protect the health of patients and staff and to comply with new State of California mandates, City of Hope staff are required to show proof of full vaccination by September 30, 2021. Compliance is a condition of employment.

• Posting Date: Oct 14, 2021
• Job Field: Research
• Employee Status: Regular
• Shift: Day Job