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Clinical Trials Office - Clinical Research Coordinators/Clinical Trial Data Coordinators (Remote/Hyb

Employer
City of Hope
Location
,
Salary
Competitive
Closing date
Jul 1, 2022
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Job Details

We are currently seeking multiple experienced Clinical Research Coordinators and Clinical TrialData Coordinatorswith Oncologyand/or Research experience in the following positions:

*Clinical Research Coordinator- Remote

*Clinical TrialData Coordinator- Remote

*Associate Clinical Research Coordinator - Hybrid (Remote & on-site in Duarte, CA)

*Principal Clinical Research Coordinator- Hybrid(Remote & on-site in Duarte, CA)

*Biospecimen Coordinator -Onsite (Duarte, CA)

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.

Clinical Research Coordinators (CRC) 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).

Basic education, experience and skills required for consideration:
  • Bachelor's Degree or a combination of edication and experiene.
  • Must have 2or more years of experience related to the management and conduct of clinical trials in an academic setting.
  • Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.

Preferred education experience and skills:
  • 2 or more years of experience related to the management and conduct of Oncology clinical trials.
  • Master's Degree.
  • SOCRA or ACRP certification preferred.

The Clinical Research Coordinator 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.

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).

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. 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. 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.

The Clinical Trial Data Coordinators must be well versed in Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, NIH guidelines, and HIPAA regulations. Theymust 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. They seeksupervision appropriately, prioritizes appropriately, completes work in a timely manner and demonstrates accuracy in all details.

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.

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.

Company

City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research.  City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation’s 20 leading cancer centers that develops and institutes standards of care for cancer treatment.

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