Regulatory Coordinator

OKLAHOMA CANCER SPECIALISTS MANAGEMENT COMPA•Tulsa, OK

About The Position

We do more than treat cancer. Be a part of the most powerful team of cancer experts and advocates who invest in the health and well-being of our patients throughout treatment and beyond. As part of the team, you will be pursuing the most advanced, innovative, and cost-effective treatment options, so that our patients receive personalized, custom care best suited to their situation. Under minimal supervision, coordinates the research and administrative activities of clinical trials for the Practices National Cancer Institute affiliation by managing Regulatory procedures. Responsible for regulatory and safety support services including trial communication and document distribution, critical document collection process, safety reporting, translation of informed consent documents and communication with sponsor representatives. Provides this support in compliance with the FDA Code of Federal Regulations (CFR), the ICH Good Clinical Practice (GCP) Guidelines, OHRP/DHHS guidelines. Supports and adheres to the Oklahoma Cancer Specialists and Research Institute Compliance Program, to include the Code of Ethics and Business Standards.

Requirements

High School diploma or equivalent required.
Minimum of one year experience in medical clinic setting.
Ability to examine documents for accuracy and completeness required.
Knowledge of medical terminology required.

Nice To Haves

An associate degree or bachelor’s degree preferred.
Two or more years of experience in Oncology/Research preferred.
Knowledge of current FDA regulations, Good Clinical Practice, governing clinical research preferred.

Responsibilities

Coordinates the research and administrative activities of clinical trials for the Practices National Cancer Institute affiliation by managing Regulatory procedures.
Responsible for regulatory and safety support services including trial communication and document distribution, critical document collection process, safety reporting, translation of informed consent documents and communication with sponsor representatives.
Provides this support in compliance with the FDA Code of Federal Regulations (CFR), the ICH Good Clinical Practice (GCP) Guidelines, OHRP/DHHS guidelines.
Supports and adheres to the Oklahoma Cancer Specialists and Research Institute Compliance Program, to include the Code of Ethics and Business Standards.