Clinical Trials Data Coordinator (Remote)

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

Under the supervision of the CRC Manager and/or CRC Supervisor, Clinical Trial Data Coordinators 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. It is their responsibility to maintain the electronic research record and maintenance of patient information in the clinical trials management system (CTMS).

The Clinical Trial Data Coordinator must be well versed in Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, NIH guidelines, and HIPAA regulations. The Clinical Trial Data Coordinator must be able to work as a member of the clinical research team with positive and timely written and verbal communication, including sharing information. 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 Clinical Trial Data Coordinator seeks supervision appropriately, prioritizes appropriately, completes work in a timely manner and demonstrates accuracy in all details.

Key Responsibilities include:

Data Management & Protocol Compliance

• Ensures all protocol procedures are ordered and completed as specified in the protocol.
• 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.
• Meets contractual or institutional requirements for timeliness of data entry and query resolution.
• Fulfills sponsor requirements related to reportable information, including AE, unanticipated problems, and other information required by the sponsor protocol.

Administration

• 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.
• Participates in audits and monitor visits for assigned studies, as requested.
• Identifies and communicates important protocol and data management issues or problems to the PI and supervisor in a timely manner.

Other related duties as assigned or requested

• Participates in study team meetings.
• Participate in staff meetings.
• 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.

Basic education, experience and skills required for consideration:

• Bachelor's Degree, relevant experience may substitute for degree.
• At least two years of experience related to the conduct of clinical trials.Oncology experience is highly preferred. Working knowledge of clinical trials, Federal, State, and Local Regulations, and IRB requirements.

Preferred experience and skills:

• Experience related to the conduct of oncology clinical trials.
• 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. The ability to focus on tasks 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 the ability to communicate well verbally and in writing. Must be able to read, interpret, and process large quantities of printed information.
• Access data in computer databases
• Compile data
• Proofread documents
• Research information
• Troubleshoot problems

Additional Information:

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.