Regulatory Specialist
4 weeks ago
This position is responsible for developing and managing various clinical study protocols related to cancer research. The successful candidate will oversee related regulatory requirements to ensure compliance and develop and maintain regulatory documents to achieve and maintain compliance with internal, external, and federal policies and regulations that apply to the conduct of clinical trials.
Key Responsibilities
- Collaborate with Principal Investigators and researchers to develop and implement research protocols in the Cancer Center OCTO, including creating participant consent forms, advertising materials, contact sheets, and other necessary documents.
- Prepare study documents for submission to the IRB, sponsor, or other regulatory authority and correspond with them as needed.
- 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.
- 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 and propose and implement changes as needed.
- Serve as a subject matter expert on regulatory-related issues and provide regulatory guidance, direction, and support to all members of the research team.
- Keep current on legislation, rules, regulations, procedures, and development and educate physicians and staff regarding changes as related to clinical research protocols.
Requirements
- A minimum of a Bachelor's degree in a scientific discipline is required.
- A minimum of three years of related research experience, with regulatory compliance experience preferred.
- Experience in a clinical research setting is preferred.
- Knowledge of and experience working with Federal Regulations and IRBs is required.
- Experience with oncology research protocols is preferred.
- Certification in one of the following: SoCRA, ACRP, PRIM&R is preferred and required within two years of hire.
- Strong communication skills, with the ability to communicate clearly and concisely both in written and verbal communication.
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