Sr Research Protocol Analyst

Location
Duarte, California
Salary
Competitive
Posted
May 13 2021
Ref
10010675
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Healthcare/Hospital
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

Clinical Research Protections (CRP) provides administrative, regulatory and operational support to the scientific review committees (Cancer Protocol Review and Monitoring Committee (CPRMC), Protocol Review and Monitoring Committee (PRMC), Biospecimen & Data Review Committee (BDRC)) and the Institutional Review Board (IRB). Senior Research Protocol Analysts manage a portfolio of human research protocols from initial submission through the protocol's life cycle ensuring that protocols are reviewed appropriately by relevant committees. Senior Research Protocol Analysts are subject matter experts in the human subject protection regulations set forth at 45 CFR 46 and 21 CFR Parts 50, 56, 312, 600 and 812 and other federal guidance, as well as the NCI Cancer Center Support Grant requirements. 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 Research Operations and City of Hope 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 may also serve as COH IRB members and conduct reviews of submissions.

Key Responsibilities include:

Protocol Management. Senior Research Protocol Analysts are expected to shepherd protocols through the scientific review committees and IRB (both internal and external) review processes to achieve a timely outcome that is compliant with applicable regulations. Senior Research Protocol Analysts are primarily responsible for the review of complex and high priority protocols as determined by COH leadership and also manage a portfolio of standard new protocols, amendments, continuing reviews, deviations, unanticipated problems and other reportable events.

•Conduct pre- review of all submissions in anticipation of scientific review committees and IRB review, including but not limited to completeness of the submission and compliance with scientific review committees and IRB policies as well as federal requirements for approval.

•Work with the Meeting Coordinator to ensure timely review by convened committee/expedited reviewer and appropriate reviewers have been assigned based on expertise

•Prepare committee minutes documenting the determinations required by the CCSG and/or applicable federal regulations

•Prepare action notices to the Investigators summarizing the committee review outcome and conditions for approval

•Monitor the timeliness of investigator responses to committee conditions and escalate as necessary to ensure timely approval.

•Pre-review investigator responses to ensure completeness and that they satisfy the conditions before routing for final approval. Liaise with investigators and study team members to address any outstanding issues.

Committee Meetings:

•Prepare materials for committee meetings for assigned protocol submissions ensuring completeness and supplement the packets with relevant reports, e.g., SAE and Deviations reports.

•For submissions raising novel regulatory questions, provide committee members with relevant reference and guidance

•During the meetings, have sufficient familiarity with the assigned protocol and submission to address committee member questions on past reviews determinations and overall history

External IRB

•For protocols under the jurisdiction of the external central IRBs, including, but not limited to NCI CIRB, NMDP sIRB, conduct a QC on the informed consent to ensure consistent and appropriate incorporation of the local boilerplate language.

•Assist in annual worksheet development and/or supplemental materials as requested.

•Assist in providing information on external institutions when asked to cede review, including facilitating the execution of reliance agreements with partner organizations.

Internal and External Audits

•Serve as a primary contact in preparing materials for internal and external audits and accreditations

•Ensure assigned protocols are audit ready with appropriate documentation is filed, current and compliant with internal and external requirements.

Other initiatives:

•Identify areas for process improvement and efficiencies that also support regulatory compliance to support a robust internal QC/QA program

•Keep up to date with current regulations and guidance. Assist with training staff on relevant regulations and impacted processes.

•Support the CRP Manager in quality improvement initiatives which may include but are not limited to policy and/or procedure development or updates, electronic form revision in iRIS, workflow updates and report and dashboard enhancements to support daily operations.

•Participate in educational sessions

Basic education, experience and skills required for consideration:

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


Required Certification/Licensure:
  • Certified IRB Professional (CIP)


Preferred education experience and skills:
  • Master's degree


  • Experience in review and processing of research protocols in an academic research setting


City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.

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  • Posting Date: Jun 18, 2021
  • Job Field: Clinical Research
  • Employee Status: Regular
  • Shift: Day Job

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