Regulatory Specialist - Cancer Center - Clinical Trials Office

University of Illinois Chicago•Chicago, IL

3d•Onsite

About The Position

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.

Requirements

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
Strong communication skills; ability to communicate clearly and concisely both in written and verbal communication.

Nice To Haves

Certification in one of the following: SoCRA, ACRP, PRIM&R preferred and required within 2 years of hire.

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.