MISSION STATEMENTThe 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 COMPETENCIESEssential Document Maintenance for Clinical Research Conduct
Collaborates with the Lymphoma clinical research team to maintain essential documents (including electronic format) necessary for compliance with the Code of Federal Regulations, Good Clinical Practice Guidelines, and institutional policies.
Ensures essential documents are up-to-date and available for review by sponsors, regulatory authorities, and auditors. This includes, but is not limited to, updating/maintaining FDA form 1572, financial disclosure forms, delegation of authority logs, physician CVs, medical licenses, training records, lab certifications and normal ranges, research/protocol training documentation, notes to file, general correspondence, sponsor correspondence, and IRB correspondence.
Communicates verbally and in writing with internal and external stakeholders to ensure that documents are completed accurately and within the required timeframes.
Assists with filing monitoring reports and follow-up confirmation letters. Provides support to new faculty and team members with Advarra eREG training setup.
Grants monitoring access to the regulatory management system and trains new users on how to use required systems.
Coordinates and prepares monthly reports of essential documents and monitor visits.
Meets weekly with Lymphoma team members to ensure no outstanding queries need to be addressed.
Departmental Protocol Priority List Maintenance
Works with research administration, the regulatory team, and faculty leads to update and maintain the protocol priority list database. Provides reports, updates, and lists for distribution in meetings and clinical areas.
IRB Submissions for Revisions/Amendments
Collaborates with the regulatory team and protocol principal investigators to assist with the submission of protocol amendments/revisions and related documentation to the submission system.
Other Duties as AssignedEducation Required - High school diploma or equivalent.Preferred Education: Bachelor's degreeExperience Required - Four years of related 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.htmlAdditional Information
Requisition ID: 173650
Employment Status: Full-Time
Employee Status: Regular
Work Week: Days
Minimum Salary: US Dollar (USD) 50,500
Midpoint Salary: US Dollar (USD) 63,000
Maximum Salary : US Dollar (USD) 75,500
FLSA: non-exempt and eligible for overtime pay
Fund Type: Soft
Work Location: Remote (within Texas only)
Pivotal Position: Yes
Referral Bonus Available?: No
Relocation Assistance Available?: No
Science Jobs: Yes
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