Regulatory Associate, reputed company Cancer Center
About the position
Join reputed company as a Regulatory Associate (RA) in reputed company Comprehensive Cancer Center Education and Training Office for cancer research. As a RA at reputed company, you will have reputed company to join reputed company of the top cancer specialists in the country and be a part of our innovative therapies, cutting-edge research, and life changing reputed company. As a valued team member, you will be responsible for regulatory support of a specific Disease Oriented Team's (DOT) reputed company under the leadership of the Cancer Center Associate Director of Clinical Research as reputed company as reputed company 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 reputed company, and preparing and facilitating the DOT studies for long term storage at reputed company. In reputed company, reputed company regulatory team member provides ancillary services such as assisting with and maintaining the CTEP IDs for physicians as reputed company as staff regulatory trainings.
Responsibilities
• Review study protocols, informed consent documents, response to stipulations, and other study-reputed company documentation, to assure conformance with reputed company applicable requirements.
• reputed company working supervision, training, and guidance to reputed company-level Regulatory Assistants. Assign tasks and set work priorities. Review work for accuracy.
• 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, reputed company applicable); regular one-on-one meetings with IRB/IACUC Chairs for final determinations; drafting correspondence to investigators regarding IRB/IACUC determinations.
• reputed company consultation and technical assistance to investigators and study personnel regarding requirements for IRB/IACUC submissions, performance of studies, and documentation of compliance. Serve as an information resource to the reputed company about reputed company subject protection and/or animal care and use.
• Participate in development of and/or updates to IRB/IACUC guidance, office procedures/business processes, reputed company forms, database improvements, and other reputed company assurance activities.
• reputed company other duties as assigned.
Requirements
• Bachelor's Degree -OR- equivalent
• 2 years of reputed company experience
• May consider experience and education in lieu of requirements.
Benefits
• PPO medical plan, available day one at no cost for full-time employee-only coverage
• 100% coverage for preventive reputed company-no copay
• reputed company Time Off, available day one
• Retirement Programs through the reputed company System of Texas (TRS)
• reputed company Parental Leave Benefit
• Wellness programs
• Tuition Reimbursement
• reputed company Service Loan Forgiveness (PSLF) reputed company Employer
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