Regulatory Specialist - Cancer Center - Clinical Trials Office

Regulatory Specialist - Cancer Center - Clinical Trials Office
Regulatory Specialist - Cancer Center - Clinical Trials Office
Hiring Department : Clinical Trials Office
Location : Chicago, IL USA
Requisition ID : 1027521
Posting Close Date : October 30, 2024
About the University of Illinois Chicago
UIC is among the nation's preeminent urban public research universities, a Carnegie RU/VH research institution, and the largest university in Chicago. UIC serves over 34,000 students, comprising one of the most diverse student bodies in the nation and is designated as a Minority Serving Institution (MSI), an Asian American and Native American Pacific Islander Serving Institution (AANAPSI) and a Hispanic Serving Institution (HSI). Through its 16 colleges, UIC produces nationally and internationally recognized multidisciplinary academic programs in concert with civic, corporate and community partners worldwide, including a full complement of health sciences colleges. By emphasizing cutting-edge and transformational research along with a commitment to the success of all students, UIC embodies the dynamic, vibrant and engaged urban university. Recent "Best Colleges" rankings published by U.S. News & World Report, found UIC climbed up in its rankings among top public schools in the nation and among all national universities. UIC has over 300,000 alumni, and is one of the largest employers in the city of Chicago.
Description:
Position Summary
This position develops and manages various clinical study protocols related to cancer research and oversees related regulatory requirements to ensure compliance. Develops and maintains regulatory documents to achieve and maintain compliance with internal, external and federal policies and regulations that apply to the conduct of clinical trials.
Duties & Responsibilities

Collaborate with Principal Investigator and researchers to develop and implement research protocols in the Cancer Center OCTO. This includes creating participant consent forms, advertising materials, contact sheets, etc.

Prepare study documents for submission to the IRB, sponsor or other regulatory authority and correspond with them as needed. Create and review documentation for institutional approval of: protocols, physicians, and clinical staff to open and/or continue participation in clinical research protocols from national clinical trials, industry, external agencies, and internal sources.

Review IRB approved documents to ensure accuracy before protocols are implemented.

Maintain accurate, complete and current information in appropriate format and databases to track clinical research compliance with FDA, NCI, UIC and sponsored guidelines, i.e. complete and process appropriate documentation as outlined by FDA, NCI, study sponsors and the university. Prepare and maintain regulatory binders for each clinical trial.

Prepare responses to IRB and sponsor questions.

Monitor progress of clinical research study developments on an ongoing basis. Propose and implement changes as needed.

Serve as subject matter expert on regulatory related issues. Provide regulatory guidance, direction and support to all members of research team.

Keep current on legislation, rules, regulations, procedures, and development; educate physicians and staff regarding change as related to clinical research protocols, university staff, affiliates, and patients.

Work with Clinical Research Manager and coordinators as needed to ensure understanding of study protocols.

Guide, train, and advise other staff members and students on techniques, methods, and procedures.

Perform other related duties and participate in special projects as assigned.

Qualifications:
Minimum Qualifications

• A minimum of a Bachelor's degree in a scientific discipline required.
• Minimum of three years of related research experience; in regulatory compliance preferred.
• Experience in a clinical research setting preferred.
• Knowledge of and experience working with Federal Regulations and IRB's required.
• Experience with oncology research protocols preferred
• Certification in one of the following: SoCRA, ACRP, PRIM&R preferred and required within 2 years of hire.
• Strong communication skills; ability to communicate clearly and concisely both in written and verbal communication.

The University of Illinois System is an equal opportunity employer, including but not limited to disability and/or veteran status, and complies with all applicable state and federal employment mandates. Please visit Required Employment Notices and Posters to view our non-discrimination statement and find additional information about required background checks, sexual harassment/misconduct disclosures, and employment eligibility review through E-Verify.
The university provides accommodations to applicants and employees. Request an Accommodation
Looking for more University of Illinois positions?
We invite you to search for positions at each of the University of Illinois locations, the University of Illinois System Office and the University of Illinois Foundation. The University of Illinois System Office supports the primary missions of teaching, research, public service, and economic development for all of the Universities and offers positions in all locations. The University of Illinois Foundation is the official fundraising and private gift-receiving agency for the University of Illinois and also offers position in all locations. Click the links below to search for other University of Illinois positions.
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The University of Illinois System is an equal opportunity employer, including but not limited to disability and/or veteran status, and complies with all applicable state and federal employment mandates. Please visit Required Employment Notices and Posters to view our non-discrimination statement and find additional information about required background checks, sexual harassment/misconduct disclosures, and employment eligibility review through E-Verify.
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