Data Coordinator 2 - Oncology Clinical Trials
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About The Position
This position performs a variety of complex duties involved providing regulatory support for the regulatory coordinators within the CTO. Duties include, but are not limited to: provide regulatory support as lead regulatory coordinator for studies, assist with sponsored and investigator-initiated trial IRB submissions including initial submissions, amendments, continuation and annual reports (completion of study documents, IRB forms, etc., as needed for each submission), IND safety reports, ensuring the submissions are in compliance within federal, state and local regulations; assist with obtaining local approvals (biosafety, radiation safety, IT requests, etc.); obtaining electronic and ink signatures, assist with submissions to the FDA for the investigator-initiated studies (initial IND requests, amendments and annual reports, submitting hard copies of each submission to the FDA) and completion of FDA forms; procurement of medical/lab supplies and creation of lab kits for investigator-initiated studies; assist in ensuring lab kits and other study materials are obtained for sponsored studies; assist in the creation of forms including source documents, case report forms and manuals (operations, CRF and lab manuals) and standard operating procedures (SOPs).
