Coordinator, Clinical Studies - Sugarland

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.

Provides administrative and patient care services for the coordination of clinical trials.

JOB SPECIFIC COMPETENCIES

Protocol Management 50%
   Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the departmental Standard Operating Procedures (SOPs) manual and as presented at departmental research meetings.
   Responsible for the overall effective operation of designated protocols to include development, design, and resolution of operations in collaboration with the principal investigator or study sponsor.
   Serves as a point of contact for interdepartmental protocol collaborations, responsible for cross- functional trainings within departmental and interdepartmental staff ensuring departments are following appropriate procedures and staff are compliant with regulatory requirements governing human subjects research.
   Provides support to study team in starting up protocols, and all study related coordination including writing, submission and maintenance of protocol related documents. Develops and maintains a processing and tracking system for all protocol related paperwork.
    Review protocol documents including abstracts, text and informed consent for relevant information.
   Screen, coordinate, evaluate, and follow the patient's participation in clinical settings.
   Reviews patient eligibility and assists in the consent process. Follows patients on studies and maintains knowledge of adverse events. Submits information on adverse events to IRB and revises consents as required.
   Schedule patient tests; keep patients informed about test results and studies
   Register patients on research protocols by verifying eligibility/exclusion criteria and entering patients in the institutional designated database(s). Communicate necessary registration information to sponsor as required by the study and/or directed by the PI.
   Assists in the collection and evaluation of data. Under supervision of the medical staff, performs protocol-specific tasks including scheduling, ordering tests, collecting and processing of specimens and study documentation of patient reported responses.
    Collaborate with the multidisciplinary team as necessary to document patient care, achieve objectives of the clinical trial, and maintain patient safety.
   Able to collect, process, store, package, and ship research specimens. Develops and maintains systems for inventory control and tracking of research specimens.

Data Management 40%
   Complete case report forms using the sponsor-provided electronic data capture (EDC) system in a timely and accurate fashion, using source documents. Responsible for query resolution.
   Compiles protocol data for manuscript submission.
    Maintain data and study documents for sponsor/monitor and internal/external audits.

Training and Professional Development 10%
   Maintains a high level of professional expertise and technical proficiency with regards to clinical research through reading, attendance to appropriate departmental meetings, in-services and institutional continuing education programs
   Maintains appropriate license and certification
   Adopts novel technologies as needed to adapt to the evolving landscape of clinical research
   Completes all departmental protocol related training and delegation of authority documents in an accurate and timely manner
   Completes all mandatory institutional training requirements
   Consults with Supervisor and/or Research Nurse Manager regarding ongoing study assignments
   Maintains working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines as well as a comprehensive understanding of the research trial process
   Maintains a working knowledge of departmental clinical trial workflow in order to communicate with the Protocol Team for proper execution of trial procedures.
   Participates in the orientation process of new Clinical Research employees as well as ongoing training of current staff regarding clinical trial execution 
   Provides protocol related inservices to professional and ancillary staff in outpatient and inpatient settings, as needed
   Serves as a resource for research personnel regarding protocol and compliance information

Other duties as assigned