Sr Research Protocol Analyst

Updated: about 1 month ago
Location: Monrovia, CALIFORNIA

About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 6,000 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 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
 
Position Summary:
This position is provides regulatory and scientific support to the institutional research oversight committees. Portfolio consists mainly of Institutional Animal Care and Use Committee (IACUC) and Institutional Biosafety Committee (IBC) protocols with some Occupational Safety and Biohazards Committee (OSBC) and Stem Cell Research Oversight (SCRO).   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 DNA and viral vectors; transportation, storage and use of biological agents including viruses.  Additionally, this position involves communication with research investigators and their staff in an effort to facilitate protocol submission and review processes and which will therefore require an understanding of the agent classifications and laboratory procedures.  The Senior Research Protocol Analyst participates in a team effort to coordinate generation and distribution of meeting agendas and develops meeting summaries/minutes reflective of the committee’s protocol review activity, deliberations and decision-making.  Maintain files of committee actions on protocols.  The position requires frequent interaction with Principal Investigators (P.I.s) and their research staff and the Institutional Official.  Coordination of research subject protection activities, including compliance with institutional policies. 
 
Essential Functions:
Provide 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
  • Assigns review path and reviewers are appropriately to meet regulatory requirements
  • Assist Principal Investigators and their research teams in drafting new protocols, amendments and renewal
  • Serve as a resource for investigators for all four committees
  • Schedule and coordinate committee meetings
  • Ensure agendas for committee meetings are complete and circulated
  • Review minutes for completeness and accuracy  
  • Initiates communication with investigators to address responses to requests for modifications
  • Ensure coordination between the relevant committees and their chairs
  • Meet with new investigators to establish their protocols at City of Hope
  • Compiles and keeps updated SOPs, workflows and policies for LRP
  • Track Member training

In depth review as required
  • Engages in a substantive pre-review of incoming protocols before it is routed to other reviewers and eventually to the committee. This pre-review  will:
    • Ensure all relevant sections and fields of a submission are complete and inherently consistent from a scientific and regulatory perspective; protocol complies with all regulations and policies; protocol is written artfully to minimize future amendments; etc.,
    • Fill substantive gaps such as lack of clarity for scientific justifications, proper identification of humane end points, consistent animal numbers (IACUC), inappropriate levels of safety measures associated with biological agents, etc. are eliminated in the protocol before it continues through the review process, and that all core training requirements have been met and all parts of the submission have been attached.
  • Work constructively with investigators to revise protocols, as needed, to bring protocols into compliance with federal and state regulations and City of Hope policies and procedures prior to distributing to committee members for review.  Consult with the LRP Director/committee chairs/veterinarians as needed to ensure accuracy of pre-review in complex cases.
  • Work extensively with new investigators prior to their arrival at to establish their protocols at  City of Hope

Supporting the Director
  • Maintains registrations with federal agencies for the IACUC, IBC, and SCRO.
  • Coordinates external audits by AAALAC, USDA, OLAW, FDA, CIRM, as well as any internal audits.
  • Schedules and plans the semi-annual research facilities inspections program (IACUC).
  • Follows up inspection with communications to facilities and labs ensure that follow-up items are documented and appropriately addressed.
  • Compiles and finalizes extensive semi-annual reports which are submitted to the Institutional Official.
  • Conduct congruence analysis to ensure that proposed animal activities are consistent with the associated funding application(s).
  • Assist with administrative duties related to drafting reports of non-compliance and required annual reports to governing agencies, including coordinating review and approval by key parties.
  • Compiles metrics and reports, identify gaps/holes in data identify opportunities for improvement and or change and make recommendations to LRP Director.
  • Oversee web site maintenance, links, documents are updated and working
  • Perform quality control and process improvement activities as required

Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan.  Practices a high level of integrity and honesty in maintaining confidentiality.

 

Performs other related duties as assigned or requested.


 
Reporting Relationships
  • Director, Laboratory Research Subjects Protection

Position Qualifications:
Minimum Education:
  • Bachelor’s Degree in a related science field
  • Experience may substitute for minimum education requirements

Minimum Experience:
  • Minimum 5-8 years relevant work experience required

Preferred Education:
  • Master’s degree

Preferred Experience:
  • Experience with IACUC, IBC committee functions,  as well as SCRO and Occupational Safety procedures. 

Skills/Abilities:
  • Knowledge of complex federal and state regulations involving the use of human and/or animal subjects and gene manipulation in research
  • Analytical skills to review research protocols for completeness.
  • Effective interpersonal skills to deal with complex, sensitive and confidential material with P.I.s and administrative and research personnel.
  • Effective writing ability to document and summarize salient points and results of meeting proceedings.  Ability to communicate the same in writing and verbally to P.I.s.
  • Ability to work as a team member in an office where there are numerous deadlines and time-sensitive issues requiring judgment and flexibility.
  • Working knowledge of relational data bases for management of research protocols.
  • Ability to pay attention to details involving protocols documents.
  • Experience in laboratory research environment or as a Research Associate.
  • Must possess strong verbal and written communication skills, excellent organization, time management and problem solving skills Present a positive professional image; demonstrating service orientation

Software:
  • Microsoft Office; Windows NT, or later; Word or WordPerfect

Machines/Equipment:
  • Personal computer
  • IACUC may require mask, gown, gloves in animal facility

Working / Environmental Conditions:
  • Office setting atmosphere and environment (in off campus satellite offices)
  • Subject to many interruptions and need to reprioritize work
  • Occasionally subjected to extended hours
  • Travel between campuses
  • Exposed to material of a confidential nature on a daily basis
  • Pressure due to deadline requirements

Physical Demands:
  • Mainly sedentary work
  • Occasional walking to meetings
  • Occasional reaching, stooping, bending, kneeling, crouching
  • Moderate to heavy physical effort (lift/carry heavy documents; push heavy cart filled with paper files, etc.)
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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