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 healthcare 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 Arizona.City of Hope's commitment to Diversity, Equity, and Inclusion
We believe diversity, equity, and inclusion are 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 ensure 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 Senior Manager, and other senior leaders in the CTO and Clinical Research Operations, with input from the Disease/Modality Team Leaders and investigators, the staff of the CTO coordinates activities to support multiple research studies of all phases.
Under the direction of the Manager, the Associate Clinical Research Coordinators (ACRC) will maintain the data integrity of assigned research studies. They are responsible for abstracting data, completing case report forms, and answering queries. They schedule sponsor monitoring visits, meet with the monitors and maintain data in an audit-ready state, meeting the requirements of the contract. ACRCs are also responsible for ensuring laboratory kits and any other necessary patient study-specific equipment are available and prepared in advance of patient visits. They are to ensure compliance with the research protocol, timely coordination of biospecimen collection, and transporting and shipping of biospecimens obtained from subjects enrolled in complex research protocols. They must oversee the shipping and management of biospecimens for their assigned studies. They will collaborate with the Biospecimen Coordinator to ensure collection and shipment records of biospecimens are properly completed and maintained. Additionally, it is their responsibility to ensure patient data, for assigned studies, are up-to-date in the clinical research management system (CRMS).Essential Functions:
Works under the supervision of the manager with direction from Study Investigators and the Senior Manager.
Works in conjunction with a mentor to develop the skills to assume more responsibility and workload.
Performs protocol specific duties required per the research protocol, including:
- Abstracts data from the medical record and completes paper and electronic case report forms,
- Maintains all necessary source documents;
- Obtains data, specimens and images from outside facilities as needed;
- Responds to all requests for data clarifications;
- Knowledgeable of sponsor requirements for timeliness of data and response to queries;
- Ensures data collection is available per contract obligations at the time of monitoring visits;
- Fulfills sponsor requirements related to reportable information, including: adverse events, unanticipated problems, other information required by the sponsor protocol.
- Participates in audits and monitor visits for assigned studies, and as requested.
The ACRC ensures adherence to protocol for specimen collection as well as sponsor specific equipment procedures:
- Ensures all study related biospecimen collections are prepare, collected, and shipped according to the protocol.
- Participates, as needed, in the preparation and/or delivery of laboratory kits or study specific equipment for patient visits.
- Guarantees the Biospecimen Coordinators complete and maintain patient-specific biospecimen documentation according to policy and regulations.
Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner.
Ensures application and adherence of Good Clinical Practices, Food and Drug Administration Rules and Regulations, NIH guidelines, HIPAA regulations, ICH guidelines, and institutional policies in relation to clinical trials.
Ensure protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements.
Enter data into the clinical research management system (CRMS) for study patient and ensure it is accurate and up-to-date.
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.Position Qualifications:
- Bachelor's degree. Experience may substitute for minimum education requirements (Associate Degree plus minimum of 2 years of experience).
- At least one year of experience related to the management and conduct of oncology clinical trials in an academic setting, or six months of experience as a Project Coordinator or Biospecimen Coordinator in the CTO. Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.
- Certification in Clinical Research, SOCRA or ACRP certification preferred.
- Excellent skills in time management, prioritization, and multi-tasking required. Strong organizational skills Ability to practice independently, strong verbal and written communication skills, organizational and critical judgment skills, and be able to interact effectively with co-workers and customers. Strong attention to detail. Ability to focus on task is essential.
- Be clearly understood by verbal communication in face-to-face encounters and by telephone. Must be able to engage in a variety of telephone and face-to-face meetings related to pending and active projects on a daily basis.
- Strong command of the English language, including spelling, writing, and verbalizing and ability to communicate well verbally and in writing. Must be able to read, interpret, and process large quantities of printed information. Foster/promote a positive image and professional appearance. Sensitivity to intercultural relations. Sensitivity to the maintenance of confidentiality
- Access data in computer data bases
- Compile data
- Proofread documents
- Research information
- Troubleshoot problems
- Use computer packages
- Use word-processing software
- Computer skills including MS Office products, Internet, and general computer proficiency required.
Working / Environmental Conditions:
- Requires use of computer via keyboard, and operating facsimile machine, calculator, printer, photocopy machine, etc. Requires the use of push-button telephone set. Must be able to master new software by utilizing available resources (other program personnel, reference manual, training classes, etc.)
- Lab Coat or Apron
- If responsible for specimen handling:
- Eye Protection/Goggles
- Face Protection
- Non-Sterile Medical Gloves
- Sterile Medical Gloves
- Academic Research Setting.
- Atmosphere and environment associated with an office setting
- Atmosphere and environment associated with patient care areas
- Tobacco free campus
- Subject to many interruptions
- Occasionally subjected to irregular hours
- Requires judgment that could affect image of City of Hope
- Occasional pressure due to deadline requirements
- Occasional travel required
- Exposed to material of a confidential nature on a regular basis
- Frequent pressure due to multiple calls and inquiries
- Contact with patients/patient families under varied circumstances
- Subject to regularly changing priorities and work assignments
- Subject to handling multiple tasks simultaneously.
- Possible exposure to infectious, radioactive or biohazardous agents
- Subject to varying and unpredictable situations
- Contact with patients/patient families under varied circumstances
- Subject to situations involving grief processes & related issues
- Possibly exposed to the risk of blood borne pathogens
- Ability to maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, manual handling, walking, visually inspecting, extended standing, sitting and repetitive motions. May be required to lift up to 15 pounds. Ability to handle multiple tasks at once.
- The estimated pay scale represents the typical [salary/hourly] range City of Hope reasonably expects to pay for this position, with offers determined based on several factors which may include, but not be limited to, the candidate's experience, expertise, skills, education, job scope, training, internal equity, geography/market, etc. This pay scale is subject to change from time to time.
- 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 a disability.