Clinical Trials Office - All positions (Remote/Hybrid/On-Site Opportunities Available)

Employer
City of Hope
Location
,
Salary
Competitive
Closing date
Oct 3, 2022

View more

Discipline
Life Sciences
Position Type
Full Time
Organization Type
Healthcare/Hospital

Job Details

*This is an active pipeline requisition*

We are currently seeking multiple experienced Biospecimen Coordinators, Associate/Clinical Research Coordinators, Clinical TrialData Coordinators, Principal Clinical Research Coordinators, Associate/Regulatory Coordinators and Managers, Clinical Trialswith Oncologyand/or Research experience.

*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)

*Associate/Regulatory Coordinator- Remote

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 education and experience.
  • 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.

Principal Clinical Research Coordinators (PCRC) are responsible for serving as leads within their respective disease teams mentoring new staff, providing task level guidance to CRCs and ACRCs, and serving as subject matter experts in key CTO processes.

Minimum Education:

Bachelor's degree.

Minimum Experience:

Minimum of five 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.

Req. Certification/Licensure:

Current certification in Clinical Research, SOCRA or ACRP Certification, or obtained within three (3) months of hire.

The Associate Regulatory Coordinator is responsible for submission of studies through the various regulatory committees, including scientific review and IRB review. The Associate Regulatory Coordinator serves as the liaison with the various IRBs who review COH research including City of Hope, Western IRB, Central IRB of the National Cancer Institute, Schulman IRB and any other IRB that may enter into an agreement with COH. They work with investigators and sponsor to address oversight committee conditions and requests for information. COH uses Integrated Research Information System (iRIS) as its electronic protocol submission system as well as OnCore as our Clinical Trials Management System (CTMS). This tract is responsible for ensuring regulatory compliance to the research protocol, adhering to all appropriate regulations.

Minimum Education:
  • Bachelor's degree. Experience may substitute for minimum education requirements (Associate Degree plus minimum of 2 years of experience).

Minimum Experience:
  • At least one year of experience related to the management and conduct of oncology clinical trials in an academic setting, or six months 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.

TheRegulatory Coordinator assists COH investigators with the submission of their human subject research to the various regulatory committees who review and approve research including scientific review and IRB review.

Under the direction of the Portfolio Supervisors, Senior Director, Clinical Trial Office and the CTO leadership team with input from the Disease Team Chairs and the Study Investigators, regulatory coordinators facilitate a prompt submission of new protocols, and amendment to research regulatory oversight committees by preparing committee applications and collecting documents for review. Regulatory coordinators also serves as the liaison to and submits research to external IRBs including WIRB and NCI CIRB for all submission types (e.g., deviations, continuing reviews, adverse events). Regulatory coordinators are also responsible for working with investigators and sponsors to address regulatory oversight committee conditions and requests for information. The COH uses Integrated Research Information System (iRIS) as its electronic protocol submission system and OnCore as the Clinical Trials Management System (CTMS).

The regulatory coordinator plays a significant role in supporting a timely study start process and is responsible for collecting and provide sponsors with regulatory documents. Regulatory coordinators must have a working knowledge of institutional, federal and state policies. The position requires frequent interaction with Principal Investigators (PIs) and their research staff including but not limited to clinical research coordinators, research nurses, data coordinators, as well as the various committee administrative staff.

Minimum Education:
  • Bachelor's degree. Experience may substitute for minimum education requirements.

Minimum Experience:
  • At least 3 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.


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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