Senior Regulatory Specialist - Cancer Center - Clinical Trials Office

University of Illinois Chicago•Chicago, IL

2d•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. Responsibilities also include senior level mentoring of regulatory staff and coordination of trainings and ongoing development, assistance with the development of standard operating procedures and advance knowledge of specialized regulatory topics.

Requirements

A minimum of a Bachelor’s degree in a scientific discipline required.
Minimum of five years of related research experience; in regulatory compliance preferred.
Minimum 3 years clinical research regulatory experience required.
Oncology clinical research experience required.
Knowledge of and experience working with Federal Regulations and IRBs required.
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.
Mentor Regulatory Specialist staff and coordinate staff trainings and ongoing professional development.
Assist in the development of SOPs, policies and guidance documents for the CTO regulatory team.
Keep abreast of and serve as the point of contact for specialized regulatory topics including, but not limited to, single IRB review, CTEP registration, single patient INDs, and ClincialTrials.gov registration and updates.
Performs other related duties and participates in special projects as assigned.