Coord, Research Data - 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 2019 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.

MD Anderson Cancer Center is a global leader in the treatment of blood cancers. The Leukemia department is one of the most successful disease-specific cancer programs in the world, as well as one of the largest. As the largest medical academic department within the Cancer Medicine division, we have 29 clinical faculty and 20 research faculty.

Key Functions

Data Management

• Assists the principal investigator in collection and evaluation of clinical research data
• Abstracts and collects patient data from electronic health record and other relevant source documents
• Demonstrates ability to gather information and determine the appropriate information to report
• Enters research study data into paper or electronic case report forms (CRFs) or local data systems as required, in accordance * with protocol requirements and departmental timelines
• Performs ongoing and concurrent review of data to ensure completeness and accuracy
• Addresses data entry omissions or inconsistencies and amends errors in a timely manner
• Provides data for study progress and patient safety reports, such as IRB continuing reviews and IND reports
• Follows and adheres to department and sponsor guidelines to accomplish and complete daily work

Protocol Management

• Under supervision of the principal investigator (PI) and research data supervisor/manager, assists the investigator in the overall conduction of assigned clinical trials
• Participates in Site Initiation Visits (SIVs), conference calls and protocol meetings
• Tracks and manages all relevant protocol paperwork and essential documents in accordance with sponsor requirements and institutional policies and procedures
• Tracks protocol-required patient labs, tests, visits, and procedures through the electronic health record
• Maintains knowledge of and assists in recording adverse events
• Creates, maintains, and provides status reports to departmental contracts and budgets team members to help facilitate appropriate study payment
• Provides coverage for other data coordinators, informs appropriate staff and arranges coverage for necessary functions when absent

Clinical Trials Coordination

• Consults with principal investigator and other department personnel verbally or in writing regarding ongoing studies
• Demonstrates excellent oral and written communication skills when contacting other institutions and agencies (i.e., NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, computer-generated reports and/or face to face
• Prepares reports for the sponsoring agency, as specified by reporting requirements (e.g., monthly, quarterly, semiannually, and annually).
• Coordinates and participates in monitoring visits and internal or external audits to ensure objectives are met
• Coordinates with research staff to identify and address any study-related issues, including but not limited to inadequate or missing source documentation, adverse event reporting and protocol deviations or violations
• Applies knowledge and experience when addressing study issues, gathering relevant information systematically and making sound decisions
• Acts as a liaison with research team, caregivers, patients as well as other institutions and agencies and initiates, develops, and manages these relationships and networks
• Works in situations involving uncertainty, shifting priorities and rapid change dealing constructively with mistakes and setbacks and demonstrating flexibility
• Maintains a level of professional expertise and credibility through attendance at both institutional and outside continuing education programs

EDUCATION

Required: High school diploma or equivalent.

Preferred: Bachelor's degree.

EXPERIENCE

Required: Two 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.html