Coordinator, Clinical Studies

Location
Houston, Texas
Salary
Competitive
Posted
September 15 2020
Ref
135813
Organization Type
Healthcare/Hospital
Coordinator, Clinical Studies

Summary

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

JOB SPECIFIC COMPETENCIES

Clinical Trial Management

Responsible for the overall effective operation of protocols which involve the collaboration of the clinical research services laboratories. This includes the development, design and resolution of operational issues in collaboration with the principal investigator or study sponsor. For designated protocols, provides leadership for effective protocol research sample collection, processing and shipment to sponsor-designated labs across the nation and worldwide. Develops SOPs for key processes and procedures for the effective management of clinical trial sampling. Prepares quality reports and metrics for the purpose of grant submissions, budget creation, clinical trial evaluations, protocol review presentations, data review events, audits, conferences, posters, and manuscripts as required by the department.

Manages new protocol start-up process. Participates in site initiation visits (SIV), audits and monitor visits, obtains clarification of outstanding issues related to sample collection, processing and shipment, and captures all the information addressed in draw sheets and team presentations. Collaborates with study sponsors to ensure lab manuals are developed correctly and are in compliance with protocol requirements. Creates collection orders in accordance with protocol requirements. 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.

Collaborates with department faculty and study chair or protocol sponsor regarding protocol amendments, and withdrawals. Develops and maintains a tracking system for monitoring revisions and amendments to protocols and revise collection sheets accordingly and timely. Incorporate revisions in the collection sheets and ensure that the CIT team is trained in new sampling procedures and/or processing techniques. Collaborates with data coordinators, research nurses, supervisor and/or managers to document study and patient care activities. Provides administrative support to departmental protocol/program managers. Requires considerable exercise of independent judgment, initiative, and a basic knowledge of medical terminology and administrative procedures.

Collaboration and Budgets

Collaborates with PIs to develop sample processing protocols and recommends best practices to achieve project goals. Compiles protocol data for manuscript submission.

Manages industry sponsor relations and acts as a liaison between sponsor representatives and the laboratory team. Performs QA audits to monitor compliance and accuracy of data. Manages sponsor queries related to all aspects of research sample collection, processing and shipment on study protocols, including accuracy of time points and quality of final product. Follows through and ensures the resolution of queries in a timely manner and to mutual satisfaction. Maintain a query database of all the queries received from industry sponsors such as ECG, bone marrow, PK, blood samples, urine, and so forth.

Training and Other

Assists laboratory management with supervisory functions, participates in the technical staff evaluation process. Provides guidance and training to department's clinical research team: research nurses, clinical studies coordinators, and data management group in research study's objectives, overall design, and specimen processing techniques. Orients and trains new CITs, Sr. CITs, and supervisors in established sample collection, processing, storage and shipment procedures

Other duties as assigned

Education Required: Bachelor's degree.

Experience Required: Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, one year of required experience.

Experience Preferred: Experience with Phase 1, 2 or 3 in clinical trials and/or previous pharmaceutical industry experience.

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

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