Clinical Trials Office - Project Manager - Regulatory (Remote)
Job posting number: #7104684 (Ref:10017622)
Posted: August 5, 2022
Application Deadline: Open Until Filled
About City of Hope
City of Hope is an independent biomedical research and treatment organization for cancer, diabetes and other life-threatening diseases.
Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy such as CAR T cell therapy. City of Hope’s translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies and numerous breakthrough cancer drugs are based on technology developed at the institution. AccessHope™, a subsidiary launched in 2019 serves employers and their health care partners by providing access to City of Hope’s specialized cancer expertise.
A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nation’s “Best Hospitals” in cancer by U.S. News & World Report and received Magnet Recognition from the American Nurses Credentialing Center. Its main campus is located near Los Angeles, with additional locations throughout Southern California and in Arizona.
City of Hope’s commitment to Diversity, Equity and Inclusion
We believe diversity, equity and inclusion is key in serving our mission to provide compassionate patient care, drive innovative discovery, and advance vital education focused on eliminating cancer and diabetes in all of our communities. Our commitment to Diversity, Equity and Inclusion ensures we bring the full range of skills, perspectives, cultural backgrounds and experiences to our work -- and that our teams align with the people we serve in order to build trust and understanding. We are dedicated to fostering a community that embraces diversity - in ideas, backgrounds and perspectives; this is reflected in our work and represented in our people.
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.
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.
Minimum Education: Bachelor’s degree.
Minimum Experience: 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 forms, and protocol development.
Pref. Certification/Licensure: Certification in Clinical Research, SOCRA or ACRP Certification.
As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.
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.
City of Hope is a community of people characterized by our diversity of thought, background and approach, but tied together by our commitment to care for and cure those with cancer and other life-threatening diseases. The innovation that our diversity produces in the areas of research, treatment, philanthropy and education has made us national leaders in this fight. Our unique and diverse workforce provides us the ability to understand our patients' needs, deliver compassionate care and continue the quest for a cure for life-threatening diseases. At City of Hope, diversity and inclusion is a core value at the heart of our mission. We strive to create an inclusive workplace environment that engages all of our employees and provides them with opportunities to develop and grow, both personally and professionally. Each day brings an opportunity to strengthen our work, leverage our different perspectives and improve our patients’ experiences by learning from others. Diversity and inclusion is about much more than policies and campaigns. It is an integral part of who we are as an institution, how we operate and how we see our future.