Research Data Specialist - Regulatory (Leukemia)

The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report's 2022-2023 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.
KEY FUNCTIONS
Regulatory Operations
· Provides oversight of clinical research protocol development and regulatory processing: collaborates with the physician, study chair or protocol sponsor regarding protocol design, planning, implementation, and evaluation.
· Liaison with the institutional research administration offices such as the SRC, IRB and FDA Submissions office; assures that all clinical research conducted by the department complies with the Institutional Review Board (IRB) or federal guidelines
· Maintains schedules for timely submission of new and revised protocols
· Provides clinical trials project oversight, strategic planning and quality assurance for research conducted in the Department of Leukemia under Principle Investigator's (PI) group
· Collaborate with other Regulatory employees to maintain and improve the protocol reference file system for maintaining, storing, retrieving and accessing up-to-date protocols, correspondence, etc.
· Coordinate and maintain various regulatory documents in accordance to the FDA guidelines and department SOPs for Sponsor/MDACC IND held studies
· Engage in regulatory quality assurance and clinical trial management on a day to day level by ensuring compliance with policies and procedures affecting the submissions review, approval, activation, regulation, and tracking of protocols.
· Responsible for intermittent audit/monitoring visits of regulatory documentation; report findings to the PI and address in a timely manner or before next site visit by the monitor.
· Attend weekly/monthly research meetings as well as site initiation meetings as required for the PI's group
Departmental Standards and Training
· Collects and reviews for accuracy required training documentation in accordance with various department and/or sponsor Standard Operating Procedures.
· Collects documents and information for site selection, departmental approval and protocol submission
· Provides direct/indirect oversight of research and/or faculty support staff in the performance of protocol related activities such as regulatory setup, activation, monitoring and reporting
· Systematically review and report on individual faculty assistant compliance with protocol-related job duties
Information Systems & Reporting
· Develops and maintains a processing and tracking system for all protocol related paperwork
· Establishes and participates in information systems for the development of research programs including writing, processing, submission and maintenance of protocols
· Reports both in detail and in summary fashion for the section and department's productivity and responsiveness on a monthly, quarterly and annual basis
· Provides protocol and protocol-related data and information for grant applications in collaboration within the department
Other duties as assigned.
EDUCATION
Required: Bachelor's degree in a related field.
Preferred: Master's degree in a related field.
EXPERIENCE
Required: Two years research study experience. May substitute required education degree with additional years of equivalent experience. With preferred degree, no experience required.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Additional Information

• Requisition ID: 162733
• Employment Status: Full-Time
• Employee Status: Regular
• Work Week: Days
• Minimum Salary: US Dollar (USD) 48,000
• Midpoint Salary: US Dollar (USD) 60,000
• Maximum Salary : US Dollar (USD) 72,000
• FLSA: exempt and not eligible for overtime pay
• Fund Type: Soft
• Work Location: Hybrid Onsite/Remote
• Pivotal Position: Yes
• Referral Bonus Available?: No
• Relocation Assistance Available?: Yes
• Science Jobs: No