Clinical Research Registration Specialist - Clinical Research Services

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.

Provide guidance and expertise for the Clinical Research Systems under the Office of Protocol Review & Reporting (OPRR) for the Office of Clinical Research Administration (OCRA). Serves as a lead Subject Matter Expert (SME) for how systems support the differing processes related to the protocol life cycle from protocol submission, patient recruitment, termination, and quality assessment of required reporting for both institutional and external. Provides back-up to the Clinical Research Systems Specialists in handling the OPRR Systems help lines. Develops and maintains the educational training modules and manuals, and ensures regulatory compliance with federal, state, local laws, and policies related to clinical research for reporting. Functions as a team resource and SME for the Clinical Research Registration Specialists and facilitates the creation of standard operating procedures for recurring processes and for best practices.

Key Functions

General

• Leads in projects as necessary in each modality.
• Assists in second level problem solving with the Clinical Research Systems as necessary.
• Provide back up for help desk support.

· Serve as an expert or knowledge base for Clinical Research Registration Specialist. Includes training, problem solving, mentoring, and project leading.

· Expand knowledge of MD Anderson Regulatory processes and procedures to improve current Standard Operating Procedures (SOPs) and their application within the Clinical Research Systems suite.

• Collaborates with the supervisor to initiate the development, maintenance, and enhancement of standard operating procedures for recurring issues or adherence to policies and compliance.

Data Analysis, Validation, and Reporting for National and Federal Requirements

• Provide support to Clinical Research Registration Specialists for the clinical research data source by supplying appropriate ad-hoc query building and reporting to validate data entry and comparisons of information from, including but not limited to, Clinical Research Systems, CTRP, and CT.gov.
• Perform the cleansing of data against known business rules or business logic for Clinical Research Systems, CTRP, and CT.gov.
• Identify, isolate and resolve issues affecting data systems, data structures, and validate data entered as a whole or in part impacting patient registrations, Data Table 4 (DT4) CORE Grant, CTRP, CT.gov, and results reporting requirements based on MD Anderson policies, federal and national regulations.

· Provide issue resolution regarding results reporting entries, and registrations within CT.gov and CTRP databases, as well as Clinical Research systems for database entry reports from Sr. Clinical Research Systems Analyst.

Help Line, Training and Education

• Assist in defining and analyzing problems escalated by Clinical Research Registration Specialists regarding Clinical Research Systems, clinical trial registrations in CT.gov, CTRP and results reporting in CT.gov.
• Serves back up for technical training classes of how to register and enter data on patients in protocols, create reports, and results reporting entry in Clinical Research Systems.
• Modifies and enhances current training modules and materials when changes are needed based on M.D. Anderson policies and national & federal regulations.

Education

Required: Bachelor's degree.

Experience

Required: Two years of clinical research experience. May substitute required education degree with additional years of equivalent experience on a one to one basis.

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: 168939
• Employment Status: Full-Time
• Employee Status: Regular
• Work Week: Days
• Minimum Salary: US Dollar (USD) 58,000
• Midpoint Salary: US Dollar (USD) 72,500
• Maximum Salary : US Dollar (USD) 87,000
• FLSA: exempt and not eligible for overtime pay
• Fund Type: Soft
• Work Location: Remote
• Pivotal Position: No
• Referral Bonus Available?: No
• Relocation Assistance Available?: No
• Science Jobs: No

#LI-Remote