Regulatory Coordinator

City of Hope • Duarte, CA 91009

Posted 2 weeks ago

Job Description

About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 5000 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.

Description:

Regulatory Support Services (RSS) 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. RSS facilitates a prompt submission of new protocols, and amendment to research regulatory oversight committees by preparing committee applications and collecting documents for review. RSS 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). RSS staff 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.

RSS plays a significant role in supporting a timely study start process and is responsible for collecting and provide sponsors with regulatory documents. RSS staff 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.

Key Responsibilities include:

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 Regulatory Coordinator III, RSS Manager, PI and research staffinformed 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.

Minimum Education and Skills Required for Consideration:

* Bachelor's degree. Experience may substitute for minimum education requirements.

Preferred Education and Skills:

* At least 2 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.

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.

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