Regulatory Specialist - Cancer Center - Clinical Trials Office

Regulatory Specialist
- Cancer Center
- Clinical Trials Office

Chicago, IL, United States

Salary:
The budgeted salary range for this position is $55,000 to $65,000. Final salary offered willbe determined by a thorough assessment of available market data, internal salary equity, candidate experience and qualifications, and budget constraints.

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.

This position is intended to be eligible for benefits . This includes Health, Dental, Vision, Life Insurance, a Retirement Plan, Paid time Off, and Tuition waivers for employees and dependents.

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.

• 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,…