Project Manager

Location
Duarte, California
Salary
Competitive
Posted
April 22 2021
Ref
10010104
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
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Under the direction of the Senior Director, Clinical Trial Office Operations and the CTO leadership team with input from the Disease/Modality (D/M) Team Chairs and the Study Investigators, the Project Manager (PM), as a senior regulatory team member and leader, assists investigators with the submission and activation of their human subject research to the various regulatory committees who review and approve research including scientific review and IRB review. The CTO regulatory team facilitates a prompt submission of new protocols, study updates, amendments and other regulatory related materials to regulatory oversight committees by preparing committee applications and collecting documents for review. The PM serves as the primary point of contact for faculty, staff and sponsors for trial submission, approval and activation at COH.
The PM is responsible for managing the initial study submission, ensuring proper D/M Team endorsement and serves as the liaison to sponsor and submits research to external IRBs such as WIRB and/or NCI CIRB. The PM oversees the ongoing regulatory management of studies for their assigned D/M Team for other submission types (e.g., deviations, continuing reviews, adverse events). COH uses Integrated Research Information System (iRIS) as its electronic protocol submission system and OnCore as the Clinical Trials Management System (CTMS). PM are also responsible for working with investigators and Clinical Trials Support Services (CTSS) for budget development, Medicare coverage analysis (MCA) and OnCore calendar builds to ensure timeliness and accuracy.
The PM plays a significant role in supporting a timely study start process and is responsible for collecting and provide sponsors with regulatory documents as well as serve as a lead and mentor to regulatory coordinators. This includes assisting leadership with onboarding, training, and implementation of new processes or changes. All regulatory coordinators must have a working knowledge of institutional, federal and state policies. The PM must have expertise in the regulatory and operations arena of clinical trials. The position requires frequent interaction with Principal Investigators (PIs) and their research staff including but not limited to clinical research coordinators, research nurses, monitors, data coordinators, as well as the various committee administrative staff.

Key Responsibilities include:
  • New Research Study Submission for Initial Approval and Activation
    • Develop and maintain knowledge of institutional protocol submission procedures and requirements.
    • Coordinate the preparation and submission of new studies to appropriate committees, including DSMC, C/PRMC, COH IRB, WIRB, CIRB and other committees as necessary, including drafting and/or editing of informed consent document.
    • Interact with appropriate institutional staff to ensure that the protocol approval process is completed in a timely manner.
    • Keep the Regulatory Coordinator(s) CTO leadership, CTSS team, PI and research staff informed of issues with the protocol approval and activation.
    • Interface with the Clinical Trial Activation and Pharmaceutical Partnerships team to determine appropriate timeliness and options for rapid activation.
    • Communicate verbally and in writing, as needed or as requested by study investigator, with internal reviewers (e.g., C/PRMC, IRB, IBC) or external agencies (e.g., pharmaceutical sponsors and/or governmental study sponsors, such as National Cancer Institute (NCI) or Food and Drug Administration (FDA) and other COH offices/department involved in the study start up process.
    • Assist in coordinating and send outgoing material and correspondence to institutional, state, and/or federal agencies.
    • Inform sponsors and collaborators of regulatory status of protocols at least monthly.
    • Interface with other teams on campus regarding activation timelines and deliverables, including but not limited to CTSS, IRB, clinical departments and sponsor.
    • Participate in budget development, MCA and OnCore Calendar builds and/or validations.
  • Regulatory Documents
    • Ensure appropriate maintenance of regulatory documentation for D/M Team studies.
    • Liaise with Protocol Coordinators, investigators, study team and sponsors, as needed
  • Professional expertise and credibility through educational programs/training.
    • Manage and oversee D/M Team meetings, including accurate and timely agendas, study endorsements, appropriate minutes and attendance recording.
    • Act as mentor to associate & regulatory coordinators and assist with their training.
    • Attend department meetings and conferences.
    • Attend approved off-site meetings and conferences.
    • Supplement education as needed through use of reference materials, lectures, etc.
    • Assist in the training and orientation of new clinical trials staff in regard to department policies and procedures for the conduct of clinical trials and the appropriate completion of data entry.
    • Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department standard work and presented at weekly staff meetings.
    • Communicate with appropriate individual(s) regarding upcoming deadlines, meetings, etc.
  • Other related duties as assigned or requested
  • Job descriptions are not intended, and should not be construed to be exhaustive lists of all responsibilities, skills, efforts or working conditions associated with a job.


Qualifications
Basic education, experience and skills required for consideration:

  • Bachelor's degree.
  • Minimum of 2 years of experience related to the regulatory management and conduct of oncology clinical trials in an academic setting. Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.


Preferred education experience and skills:
  • Certification in Clinical Research, SOCRA or ACRP Certification


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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