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About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 6,000 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.
Position Summary:
The regulatory 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.
Essential Functions:
New Research Study Submission for Initial Approval and Activation
- Develop and maintain knowledge of institutional protocol submission procedures and requirements.
- Maintain a processing and tracking system for all protocol related paperwork.
- Collect and develop criteria information for protocol submission.
- Coordinate the preparation and submission of new studies to appropriate committees, including DSMC, C/PRMC, COH IRB, WIRB, CIRB and other committees as necessary, including drafting and/or editing of informed consent document.
- Interact with appropriate institutional staff to ensure that the protocol approval process is completed in a timely manner.
- Keep the Senior Regulatory Coordinator, RSS Manager, PI and research staff informed of issues with the protocol approval and activation
- Communicate verbally and in writing, as needed or as requested by study investigator, with internal reviewers (e.g., C/PRMC, IRB, IBC) or external agencies (e.g., pharmaceutical sponsors and/or governmental study sponsors, such as National Cancer Institute or Food and Drug Administration and other COH offices/department involved in the study start up process.
- Assist in coordinating and send outgoing material and correspondence to institutional, state, and/or federal agencies.
- Inform sponsors and collaborators of regulatory status of protocols at least monthly.
- Provide back up to Regulatory Coordinator III in providing updates to Disease Teams on protocol status.
Post Initial Approval Submissions (Amendments, Continuing Reviews, Deviations, etc.)
- Prepare submission of the revision of existing protocol and consent documents to appropriate committees.
- Complete forms and comply with institutional, state, and/or federal regulations for study initiation, conduct, and termination.
- Coordinate regulatory correspondence.
- Interact with appropriate institutional staff for amendments to clinical trials.
- Keep the PI and research staff informed of status of amendments.
- Participate in research audits, as required.
- Communicate verbally and in writing, as needed or as requested by study investigator, with internal reviewers (e.g., C/PRMC, IRB, IBC) or external agencies (e.g., pharmaceutical sponsors and/or governmental study sponsors, such as National Cancer Institute or Food and Drug Administration).
Regulatory Documents
- Assist in maintaining Regulatory Binder for each study, including updating FDA Forms 1572 and Financial Disclosures as needed.
- Liaise with Protocol Coordinators, investigators, study team and sponsors, as needed.
Professional expertise and credibility through educational programs/training.
- Attend department meetings and conferences.
- Attend approved off-site meetings and conferences.
- Supplement education as needed through use of reference materials, lectures, etc.
- Assist in the training and orientation of new clinical trials staff in regard to department policies and procedures for the conduct of clinical trials and the appropriate completion of data entry.
- Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department standard work and presented at weekly staff meetings.
- Communicate with appropriate individual(s) regarding upcoming deadlines, meetings, etc.
Other related duties as assigned or requested
- 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.
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:
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.
Pref. Certification/Licensure:
- Certification in Clinical Research
Skills/Abilities:
- 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.
Software:
- Computer skills including MS Office products, Internet, and general computer proficiency required.
Machines/Equipment:
- 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.)
Working / Environmental Conditions:
- Academic Research Setting.
Physical Demands:
- 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.
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.
