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.Position Summary
The Clinical Trial Office (CTO) assists COH investigators with the management of research studies involving human subjects. Under the direction of the Vice President, Clinical Research Operations and the CTO leadership team with input from the Disease Team Chairs and the Study Investigators, the staff of the CTO coordinates activities to support multiple research studies of all phases. This is an on-site position in Irvine, CA.
Clinical Research Coordinators (CRC) - Oncology at theLennar Foundation Cancer Center,are responsible for maintaining data integrity of multiple assigned research studies. They are responsible for abstracting data, completing case report forms (CRFs) and answering queries. They schedule and meet with sponsor monitor visits and maintain data in an audit ready state, meeting the requirements of the contract. CRCs are also responsible for ensuring compliance to the research protocol and all appropriate regulations. It is their responsibility to create and maintain the research record and maintenance of patient information in the clinical trials management system (CTMS).
The CRC must be well versed in Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, NIH guidelines, and HIPAA regulations. If not already, s/he must become familiar with institutional policy and procedures regarding conducting multiple clinical research trials. Develop and maintain knowledge of institutional protocol submission procedures and requirements. The CRC must be able manage multiple medium to high complexity research projects ensuring quality research conduct, achievement of expected time lines and deliverables, and efficient use of human and practical resources. The CRC must be able to work as a member of the clinical research team with positive and timely written and verbal communication, including sharing information up, down and laterally. This includes communicating protocol deviations or issues with study execution. They are to ensure protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements. The CRC seeks supervision appropriately, prioritizes appropriately, completes work in a timely manner and demonstrates accuracy in all details.Key Responsibilities include: Protocol Compliance
- Ensures all protocol procedures are ordered and completed as specified in the protocol.
- Assembles lab kits and other supplies in preparation to obtain required bio-specimen samples and transport to appropriate laboratories for processing; ships samples externally according to IATA requirements.
- Optimizes the safety of research subjects by ensuring any adverse events (AE) are appropriately reported to the sponsor, study team and institution according to protocol and regulatory requirements.
- Abstracts data from the medical record and completes paper and electronic CRFs including responding to any requests for data clarification.
- Ensures data accuracy with source documentation.
- Ensures documentation processes are followed according to GCP.
- Maintains all necessary patient source documents for assigned studies.
- Obtains data, including images, specimens and medical records, from outside facilities, as needed.
- Responds to all requests for data clarifications of assigned studies.
- Point person to receive AE notification from study team and ensures AE is followed up and/or resolved, as applicable.
- Meets contractual or institutional requirements for timeliness of data entry and query resolution.
- Fulfills sponsor requirements related to reportable information, including: AE, unanticipated problems, other information required by the sponsor protocol.
Other related duties as assigned or requested
- Participates in required teleconferences, study meetings, both on and off-site, as required.
- Attends Disease/Modality Team meetings to ensure any issues are communicated to the team.
- Schedules and participates in interim monitoring visits (IMV) for source data verification (SDV).
- Reviews monitoring reports for assigned studies, determines any discrepancies and resolves outstanding data issues identified by the monitor.
- Adheres to IMV policies of COH.
- Assist the Epic Protocol Content Administrators (PCAs) with questions regarding the protocol procedural requirements, including lab tests, EKG's or imaging.
- Participates in audits and monitor visits for assigned studies, and as requested.
- Identifies and communicates important protocol and data management issues or problems to the PI and supervisor in a timely manner.
- Ensures all patients, for assigned studies, are entered into the CTMS according to COH policies and status is correct.
- Updates patient data in the CTMS to ensure appropriate patient calendars are utilized.
- Assist Clinical Research Billing (CRB) with resolving outstanding data issues or inquiries for financial concerns.
- Participate in the validation of the Epic treatment plans and CTMS calendars for assigned studies.
- Responds to colleagues, faculty, leaders and sponsors in a timely manner.
Basic education, experience and skills required for consideration:
- Participates in study team meetings.
- Participate in staff meetings.
- Participate in at least 1 CTO working group/committee each year.
- Identifies and participates in professional development activities and opportunities.
- Serve as a resource to other staff regarding assigned protocols.
- Other duties as assigned.
- 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.
Preferred education experience and certification:
- Bachelor's Degree or a combination of education and experience.
- Two or more years of experience related to the 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.
- Bachelor's or Master's Degree preferred.
- SOCRA or ACRP certification preferred.
- 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.