Clinical Research Regulatory Coordinator I Resume Example

Regulatory

• Coordinate and implement regulatory and Institutional Review Board (IRB) activities as required in the management of site clinical trials research involving the collection, and documentation of regulatory processes
• Manage regulatory documents such as IRB approvals, sponsor memos, safety reports, statistical reports, adverse events, and ancillary IRB regulatory documents electronically and in the study binder.
• Prepare and submit IRB applications to open and maintain Regulatory documentation and submission for Cooperative Group studies such as Alliance, NRG, and RTOG Studies.
• Update OnCore with IRB approvals and amendment
• Obtain principal investigator's signature for study trial regulatory documents
• Maintain study trial delegation of responsibility logs and meeting attendance
• Correspond with study sponsors and other regulatory personnel
• Submit IRB personnel contact update forms
• Submit and ship FDA IND Application Forms (e.g., Form 1571, FDA Form 1572, and Form 3674 )

Administrative

• Complete and submit pharmacy and hospital invoices for the clinical trials
• Assist the clinical coordinators, research nurses, and other hospital staff with clinical trial regulatory compliance
• Prepare and maintain consent wall folders with copies of the latest IRB approved consents for the ease of physicians seeking to enroll patients.
• Ensure that physicians are current on their IRB training and CTEP and NCI RCR registration
• UAB Hospital Study Trial Invoices and UAB Patient Financial Services UAB Hospital Internal Payment Form and UB
• Update Cooperative Group Trials monthly accrual documents for submission
• Coordinate UAB Department of Radiation Oncology Science Hour presentations
• Complete and submit Research Summary Forms for IMPACT Banners.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.