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Regulatory Associate, Simmons Cancer Center
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- Regulatory Associate, Simmons Comprehensive Cancer Center - Cancer Research
- Join UT Southwestern as a Regulatory Associate (RA) in Simmons Comprehensive Cancer Center Education and Training Office for cancer research.
- As a valued team member, you will be responsible for regulatory support of a specific Disease Oriented Team\'s (DOT) clinical trials under the leadership of the Cancer Center Associate Director of Clinical Research as well as provide support and backup for other DOTs as needed.
- The primary role of the regulatory team is to review study protocols, draft consent forms, complete IRB and/or FDA submissions (initial, modifications/amendments, continuing reviews, and study closure), maintenance of essential regulatory documents both electronic and paper, and preparing and facilitating the DOT studies for long term storage at Iron Mountain.
- Administer expedited and exempt research review processes, including, but not limited to intake of protocols and assessment of review level (with referral to full IRB/IACUC, when applicable); regular one-on-one meetings with IRB/IACUC Chairs for final determinations; drafting correspondence to investigators regarding IRB/IACUC determinations.
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