Quality Assurance Specialist - Lymphoma Myeloma

MISSION STATEMENT
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.

JOB SPECIFIC COMPETENCIES

Protocol Administration

• Assists the investigator in the overall conduct of clinical trials as assigned. Participates in the departmental protocol review and submission process and actively participates in protocol meetings such as investigators and initiation meetings as required. Provides all study-related coordination including writing, submission, and maintenance of protocols.
• Develops and maintains a processing and tracking system for all paperwork. Collects and develops criteria information for protocol submission.
• Manages protocols at appropriate intervals. Ensures conduct of assigned studies is in accordance with Good Clinical Practice, federal regulations, and institutional policies. Interacts with NCI and the pharmaceutical industry to correct/update protocol documents. Communicates verbally and in writing as needed or as requested by the principal investigator of the study, internal reviewers, external agencies, Institutional Review Board, and Clinical Research Committee.
• Assists with training other support staff in study coordination, submission process, and regulatory duties as assigned.
• Participates in protocol monitoring, audits, and follow-up along with coordinators of research data. Leads all data management efforts for clinical trials as assigned by team and as needed based on departmental priorities.
• Provides Quality Assurance to ensure consistency between clinical trials and related documents and that the documents are written in accordance with institutional and federal guidelines governing clinical research and lab protocols.
• Maintains up-to-date knowledge of departmental and institutional databases for the execution of clinical trial workflow.
• Participates in PI, team, and departmental meetings to communicate key regulatory information to the research team.
• Participates in routine monitoring visits and provides sufficient, appropriate, and timely responses to sponsor, monitor, or auditor regulatory queries.

Coordinate Regulatory Correspondence on Clinical Research Studies

• Communicates verbally and in writing, as needed or requested, by PI with internal reviewers or external agencies (pharmaceutical companies and/or government sponsors).
• Completes forms and complies with institutional, state, and federal agency requirements; prepares reports for the surveillance committee and the sponsoring agencies as specified in the reporting requirements.

Protocol Monitoring, Audits, Follow-Up, and Management of Protocol/Regulatory Binder

• Participates in protocol monitoring, management, audits, and follow-up.
• Leads all regulatory management efforts for assigned Principal Investigators.
• Ensures conduct of assigned studies is in accordance with Good Clinical Practice, federal regulations, and institutional policies.
• Interacts with NCI and the pharmaceutical industry to correct/update protocol documents.
• Communicates verbally and in writing as needed or as requested by the principal investigator of the study, internal reviewers, external agencies, Institutional Review Board, and Scientific Research Committee.

Quality Management

• Acts as a resource for reviewing and revising regulatory Note to Files, SOPs, training guides, and checklists.
• Responsible for ensuring the regulatory data is entered into QuickBase and Advarra eREG accurately and consistently.
• Performs quality checks on the data entered in QuickBase and Advarra eREG. Checks for completeness in the systems.
• Assists with regulatory corrective and preventative actions (CAPA) and in their timely implementation, if needed.
• Participates in audit meetings, including planning, training, management of audit reports, communication of deficiencies, and follow-up of action items as it relates to regulatory.

Other Duties as Assigned

Education Required - Bachelor's degree in Healthcare, Nursing or a related healthcare field.

Experience Required - Three years of professional experience in a healthcare or academic setting with one year experience with research protocols, regulatory compliance or education. May substitute required education with additional years of equivalent experience or applicable degree 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: 173648
• Employment Status: Full-Time
• Employee Status: Regular
• Work Week: Days
• Minimum Salary: US Dollar (USD) 77,500
• Midpoint Salary: US Dollar (USD) 97,000
• Maximum Salary : US Dollar (USD) 116,500
• FLSA: exempt and not eligible for overtime pay
• Fund Type: Soft
• Work Location: Remote (within Texas only)
• Pivotal Position: Yes
• Referral Bonus Available?: No
• Relocation Assistance Available?: Yes
• Science Jobs: Yes

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