MD Anderson Cancer Center Human Research Regulations Specialist - Protocol Review & Reporting in Houston, Texas

The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in

Texas, the nation, and the world through outstanding programs that integrate patient care,

research and prevention, and through education for undergraduate and graduate students, trainees,

professionals, employees and the public.

The Human Research Regulations Specialist conducts the daily operations of the Scientific Review Committee # 4 (SRC 4) which includes supporting the review, approval, and revision process for all clinical protocols submitted. This position also helps to support the Protocol Review and Monitoring System (PRMS) which is a required function of our NCI Cancer Center Support Grant

(CCSG). Functions as a subject matter expert in regarding to the scientific review process. Works with Principal Investigators (PIs), regulatory staff as well as other groups throughout the institution regarding the process. Collaborates with Manager and Director to identify quality improvement opportunities and participants in programming needs. Provides assistance regarding system applications to MD Anderson Cancer Center (MDACC) PIs and regulatory staff. Responsible for entering data, cleaning data and maintaining data that is reported to Institutional Leadership and the National Cancer Institute (NCI). Collects metrics and participates in departmental quality assurance

activities.

Key Functions:

  • Analyzes research applications received by Protocol Review and Reporting for regulatory compliance, and recommends appropriate revisions.

  • Ensures proper administrative handling of the research application and timely submission to the appropriate agency.

  • Provides specialized technical assistance on applications to MD Anderson Cancer Center (MDACC) faculty and staff.

  • Prepares and maintains documentation on administrative flow of MDACC research applications.

  • Cleans, obtains and maintains data. Creates complex reports for use in reviewing specific application information and general trends.

  • Collects metrics and participates in department quality assurance.

  • Develops recommendations on operations and processes.

  • May design and provide education training sessions for faculty, draft institutional communications and/or act as a coach and team leader.

Education

Required: High school diploma or equivalent.

Preferred: Bachelor's degree.

Experience

Required: Five years related experience, with specific experience in supporting administrative or research projects. May substitute equivalent years of preferred education for required experience on a one to one basis.

Preferred:

  • Research experience working with Protocols.

  • Previous experience with PDOL and CORe.

  • Well versed in Adobe and Microsoft Excel.

Certifications

Preferred: Certified Clinical Research Professional (CCRP); Certified IRB

Professional (CIP); Certified IRB Manager (CIM)

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

  • Employee Status: Regular

  • Minimum Salary: US Dollar (USD) 46,900

  • Midpoint Salary: US Dollar (USD) 65,700

  • Maximum Salary : US Dollar (USD) 84,500