Clinical Research Coordinator V

University of Louisville•Aurora, CO

1d•$48,225 - $72,389•Onsite

About The Position

The primary responsibility of the Clinical Research Coordinator V is to manage all aspects of conducting clinical trials at the Brown Cancer Center. The Clinical Research Coordinator V is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for the protocols, the Clinical Research Coordinator V will act as liaison between the investigators, health care providers, regulatory staff, and internal or external sponsors, to screen, enroll, and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. The Clinical Research Coordinator V will Consult with the the PI to ensure appropriate protocol for enrollment has been completed and approved. In addition, the Clinical Research Coordinator V is responsible for all data and source documentation, adverse experience reporting, and collaboration with the regulatory and financial staff for maintenance of complete files. The position will be responsible for attending Multidisciplinary Clinics and Conferences, workshops, and other learning opportunities appropriate for care management of the clinical trial patient. This position will also have responsibility to assist in the maintenance of the Clinical Trial Database, ensuring timely input of research activity and other duties as assigned.

Requirements

Bachelor's degree in a related field and two (2) or more years of relevant research experience, or an equivalent combination of education and work experience.
In-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations.
Ability to screen, enroll, and follow study subjects, ensuring protocol compliance and close monitoring.
Ability to consult with the PI to ensure appropriate protocol for enrollment has been completed and approved.
Responsibility for all data and source documentation, adverse experience reporting, and collaboration with regulatory and financial staff for maintenance of complete files.
Attendance of Multidisciplinary Clinics and Conferences, workshops, and other learning opportunities appropriate for care management of the clinical trial patient.
Assistance in the maintenance of the Clinical Trial Database, ensuring timely input of research activity.

Nice To Haves

3+ years of experience as a clinical trial coordinator in an oncology setting
SOCRA or other professional certification in clinical research
Demonstrated capacity to create supportive work environments
Demonstrated capacity to collaborate effectively on teams
Demonstrated capacity to serve the students we admit and aim to attract

Responsibilities

Coordinates all aspects of clinical trials initiation to ensure full compliance with sponsors and FDA, possesses an in-depth understanding of each protocol assigned, participates as a team leader in planning the study conduct at the site, and verifies all regulatory requirements are fulfilled for subject enrollment before subject recruitment begins.
Plans patient recruitment methods, Oversees and Mentors junior Research Coordinators to ensure proper screening for potential patients to determine eligibility, Consults with PI on inclusion/exclusion criteria. Informs faculty of potential eligibility, educates patients and family members on appropriate clinical trials available; develops resources and materials for patient/family teaching; reviews and verifies all relevant source documentation in subject's record before subjects are enrolled; and documents protocol exemptions and deviations as appropriate.
Oversees and ensures the coordination of logistics of patient visits and clinical activity, including ordering/scheduling of all tests required for protocol, to ensure adherence to protocol requirements; coordinates information between all involved parties and departments such as pharmacy, radiology and others.
Organizes and if needed conducts protocol in-services and education for all staff involved with the protocol to elicit compliance with protocol specific requirements specific requirements and regulation; ensure distribution of appropriate forms, supplies, equipment, and lab samples.
Coordinates with medical staff to accurately reflect treatment orders to ensure adherence to protocol requirements and follows study subjects; evaluates toxicities and adverse events (AEs) and keeps investigators appraised of necessary modifications of study; and identifies potential problems and inconsistencies and takes action as appropriate.
Manages all aspects of the trial including timely and accurate CRF completion for each study subject, timely data entry in CTO trial management system, timely and appropriate reporting adverse events (AEs) and resolution of queries; and reviews and maintains source documentation for all CFR entries including clinic visit notes, lab data and procedure reports.
Maintains a high level of self-education with attendance of multi-disciplinary conferences, semiannual meetings, professional oncology meetings, workshops and other learning opportunities appropriate to research methodologies, and maintains appropriate certifications.