Clinical Trials Project Coordinator (Hybrid)
Job posting number: #7100455 (Ref:10016281)
Posted: May 20, 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 supervision of the Project Coordinator Manager, the Project Coordinator (PC) provides support to the Clinical Trials Office (CTO) in the coordination, implementation and management of administrative and regulatory duties in the department.
- Schedule D/M Team meetings according to current institutional policy.
- Ensure meeting has appropriate format or location to be conducted in an efficient and appropriate manner with adequate resources (i.e. web conference, or teleconference or in-person meeting room is booked).
- Ensure D/M Team agenda is completed according to institutional timelines and distributed to team members prior to the meeting.
- Take or transcribe D/M Team meeting minutes and ensure accuracy, completeness and distribution according to institutional policy.
- Ensure timely communication regarding meeting cancellations or location changes.
- Adhere to the established D/M Team meeting schedules.
- Ensure any administrative follow-up from D/M Team meetings is completed, such as communication with members, updates of open issues, or notifications to Sponsor Relations or Community Practices.
- Serve as the primary contact for general status inquires for new studies in assigned D/M Team.
- Coordinate with Senior Regulatory Coordinator updates for D/M Team meetings.
- Ensure study is established in Initiate the task list in the clinical trials management system (CTMS) in order for the activation timeline to start.
- Ensure regulatory binder is created in the e-regulatory platform according to institutional standards.
- Ensure sponsor directed regulatory platforms are established and up-to-date.
- Complete and manage regulatory documents for industry and other sponsors, such as, FDA Form 1572, financial disclosures, protocol cover pages, and other documents required for study start up.
- Coordinate and schedule study initiation visit (SIV) for the Duarte campus.
- Maintain regulatory files and ensure completeness for assigned trials. This includes filing and ensuring essential documents are up-to-date.
- Maintains and updates the investigator brochure (IB) library.
- Coordinate and schedule close out visits (COV) for the Duarte campus.
- Ensure study master file (SMF) is archived according to institutional policy.
- Participate in quality improvement activities
Performs other related duties as assigned or requested.
Minimum Education: Bachelor’s Degree; or AD/GED with 2 years clerical or similar experience.
Preferred Education: BA/BS degree.
Preferred Experience: Knowledge of Clinical Research and regulatory forms.
Professional demeanor, critical thinking, excellent communication and organizational skills to work with a wide audience.
Excellent verbal communication and telephone skills.
Excellent written communication skills.
Works well in a team setting.
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.