Clinical Studies Coordinator - Anesthesiology, Critical Care & Pain - Research Support

Mission Statement

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.

Clinical Studies Coordinator opportunity in the Anesthesiology, Critical Care & Pain - Research Support Department. The ideal candidate will have a bachelor’s degree and three years of experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience.  Experience in clinical trials research in an academic, pharmaceutical, or clinical research organization (CRO) are preferred.

Shift: Monday-Friday 8:00 am-5:00 pm typically (may vary based on research needs)

Summary

Provides administrative and patient care support for clinical trials within the division, ensuring protocol compliance, data integrity, and coordination with investigators, sponsors, and regulatory bodies.

Key Functions

Protocol Administration and Reporting

•    Provides all study related coordination including writing, submission and maintenance of protocols, and corresponds with IRB for approval/activation/continuation; primary contact to sponsor and CRO
•    Clean, standardize, and validate raw data to ensure accuracy and usability. Provides results to investigators to support publication. Develop progress reports (interim and final) to send to the sponsors (both government agencies and private sponsors)
•    In collaboration with the principal investigator and research supervisor, develops and maintains a processing and tracking system for all protocol related paperwork
•    Develops and maintains regulatory binders, uses CTMS systems, maintains organized case report forms and source documents
•    Works with principal investigator to compile protocol data for manuscript submission
•    Manages and coordinates responses to sponsor data queries
•    Coordinates FDA submissions and prepares for clinical trial audits for assigned protocols
•    Primary contact for site monitors and coordinates data requests
•    Generates reports as requested by faculty as needed

Clinical Research Activities

•    Under supervision of the medical staff and research supervisor, performs protocol-specific tasks including screening, ordering tests, collecting specimens, and study documentation of patient reported responses
•    In collaboration with the principal investigator and research supervisor, develops patient care methodology for protocols, including criteria for patient participation; screens patients using ONEConnect/EPIC software and interacts with any departments within and/or outside the institute that are involved with the PI’s research project.
•    Obtain patient consent for minimal risk studies, collect data while maintain patient confidentiality
•    Using OnCore and OneConnect/EPIC systems to review patient eligibility of potential study cases and assists in obtaining consents
•    Collaborates with principal investigator in the collection and evaluation of data, enters data into case report forms, documents patient care and maintains necessary data for audits
•    Accurately tracks protocol related labs, responses, and research tests; coordinates with relevant testing centers and sponsor
•    Influences project direction and outcomes by identifying opportunities to enhance, terminate, or re-direct research activities
•    Mentor students/volunteers on taking consent and data collection; supervise the research assistant; and train residents/attending on using airway devices per protocol instructions
•    Coordinates with Investigational Pharmacy, sponsor, principal investigator, for site initiation and visits
•    Follows patients on studies and maintains knowledge of adverse events. Submits the required adverse event paperwork to OPR, sponsor, and FDA as required
•    Schedules patient tests, keeps patients informed about test results and studies; serves as an information source regarding status of samples collected from patients on given protocols for PI and sponsors

Administrative Duties

•    Assists in the preparation and writing of research reports, manuscripts and abstracts for presentation and publication
•    Ability to develop and present posters regarding research interests at scientific conferences
•    Maintains quality control checks and a safe environment in compliance with all governmental and University policies, rules, regulation and code
•    Attends planning clinics and meetings, maintains contact with other institutions participating in studies. Interacts with pharmaceutical/device industry representatives
•    Organize and participate in Texas Society of Anesthesiology Difficult Airway Workshop and the bi-monthly pig tracheas labs
•    Order supplies for research, organize research staff meetings to resolve issues and prioritize activities
•    Other duties as needed