Coordinator, Research Data

Position Title: Coordinator, Research Data (Protocol Start Up and Maintenance)

Department: CTRC

Summary

The primary purpose of the Research Data Coordinator is to assist with administrative communication in collaboration with the CTRC Lab Study Coordination Team, research teams and principal investigators in order to provide independent assessment of both research and patient care services and operational management for clinical trials. Duties include but are not limited to: 1) assist in the development, maintenance and improvement of data extraction, collection, verification, coding and entry processes for laboratory budgets, data collection sheets and fax order sheets; 2) maintain timely and accurate data/document submission; 3) assist in the preparation of information and reports for abstracts, manuscripts and grants.

JOB SPECIFIC COMPETENCIES

Forms and Budget Development

• Develops laboratory protocol budgets as related to services provided by CTRC Lab.
• Designs forms (collection and fax order sheets) within LIMS related to specimen collection, processing and shipping according to the approved version and laboratory/procedure manual, assuring specimen integrity is maintained throughout the process.
• Accesses multiple systems (PDOL, ePTRCL, Microsoft Excel/Office, LIMS, etc.) to ensure accurate completion and entry of protocol required documents.
• Participates in the Site Initiation Visits (SIV's) with the assigned Clinical Studies Coordinator.

Quality Assurance

• Collaborates with the Clinical Studies Coordinator and study sponsors to ensure lab manuals and sample collection kits are developed correctly and are in compliance with the protocol requirements.
• Review kits/materials/AWBs/supplies prior to completion of protocol required documents.
• Familiar with the LIMS system (ARMADA).
• Actively participates in self quality assurance checks of all protocol required documents. This includes verification of information recorded in the LIMS system to ensure accurate completion of budgets, fax order and data collection sheets.

Communication and Coordination of Services

• Solicits information from Central Lab Staff, Research Study Teams, and Sponsor Monitors to clarify protocol requirements.
• Shares information with the Clinical Studies Coordinator via training manuals and other documents beneficial to continuing education of the protocol.
• Communicates with the Clinical Studies Coordinator regarding new protocols and procedures.
• Effectively communicate in both written and verbal forms and interact with all members of the laboratory teams, research study teams, study coordination team to ensure accurate development and revision of protocol required documents.
• Demonstrate excellent oral and written communication skills when contacting internal regulatory entities, other institutions, external agencies/entities (i.e. NCI, Consortium, sponsoring agencies, etc.) by phone, email and/or face to face interactions.
• Cooperates with both internal and external customers demonstrating calmness, self-control and emotional restraint under varying environmental circumstances; remains willing and capable of assisting with crisis.
• Adapts, facilitates, recommends and assures implementation of changes in the work environment which are conducive to the continuance of customer/client satisfaction.

Laboratory Services/Other duties as assigned

• Maintains all laboratory specific training to ensure compliance (e.g. GCP, EH&S Safety in a Laboratory Environment).
• Requires flexibility in work schedule due to operational requirements.

High school diploma or equivalent. Preferred degree: Bachelor's degree 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