Coordinator, Clinical Studies - CTRC Research

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.

The Coordinator, Clinical Studies collaborates with the research team and principal investigator to provide independent and advanced assessment of both research and patient care services and operational management for clinical trials. Impacts the efficient analysis and timely processing of research protocols and contributes to the care of patients enrolled in designated protocols. Ensures strict adherence to the policies and procedures of the institution.  Impacts the successful conduct of research clinical trials, the appropriate evaluation and reporting of these trials, and the reputation of the PI, the department, and the cancer center as a center of excellence for patient-oriented research.

Key Functions

1.       Clinical Trial Management (50%)

• Responsible for the overall effective operation of protocols which involve the collaboration of the CTRC. For designated protocols, provides leadership for effective protocol research sample collection, processing and shipment to sponsor designated labs across the nation and worldwide.
• Manages new protocol start-up process. Participates in site initiation visits (SIV) to obtain clarification of issues related to sample collection, processing and shipment.
• Creates collection sheets in accordance with the protocol requirements. 
• Requires considerable exercise of independent judgment, initiative, and a basic knowledge of medical terminology and administrative procedures.
• Participates in monitor visits, conducting QA audits to ensure data accuracy and compliance.

2.       Stakeholder Collaboration (25%)

• Collaborates with study sponsors to ensure lab manuals and sample collection kits are developed correctly and are in compliance with the protocol requirements.
• Collaborates with research teams and protocol sponsors for protocol amendments and withdrawals, updating collection sheets accordingly within the LIMS system (ARMADA)
• Coordinates with teams and sponsors to ensure lab manuals and sample kits meet protocol requirements.
• Manages industry sponsor relations, acting as a liaison between sponsor representatives and the lab team.
• Handles sponsor queries on sample collection, processing, and shipment, ensuring timely resolution and satisfaction, while also managing kit inventory in the LIMS system and ensuring proper sample storage.

3.       Laboratory Involvement (25%)

• Assists with laboratory management for designated trials.

• Presents new studies to the technical team, provides an overview of each study objective, overall design, and schedule of research assessments.

• Monitors the start-up process and ensures that the technical lab personnel and supervisors are fully knowledgeable of their functions.

• For amendments, incorporate revisions in the collection sheets and ensure that the technical staff are trained in new sampling procedures and/or processing techniques.

• Conducts quality control and trial monitoring of all samples collected, processed and shipped that have been entered into the LIMS system.
  

4.       Other Duties as Assigned