This job was posted by https://illinoisjoblink.illinois.gov : For more
information, please see:
https://illinoisjoblink.illinois.gov/jobs/11881423 Department
BSD PED - Clinical Trials Office: COG and HemOnc Research
About the Department
In the Department of Pediatrics at the University of Chicago, we strive
to provide the highest level of complex care for children from diagnosis
and treatment to conducting research to find promising new therapies
with a focus on teaching. We are committed to advancing the frontiers of
knowledge, and the education and training of future clinical
pediatricians, subspecialists, educators, clinical investigators and
physician-scientists. The Department of Pediatrics is a dynamic,
stimulating place to work, and because we are focused on growth and
improved excellence, our staff have particularly challenging and
rewarding roles.
The Pediatric Clinical Trials Office (Peds CTO) is an existing
centralized support office that provides services and high-level
guidance to individuals (faculty, investigators, research staff, and
clinic coordinators from the University and Hospital) involved in human
subjects research. The Peds CTO is responsible for establishing
standards, operating procedures, policies and practices, implementing
educational and training programs, developing communication tools, and
managing the administrative functions that impact individuals involved
in clinical research.
Job Summary
The Clinical Research Coordinator (CRC) 2 in Pediatrics provides support
to the Solid Tumor Phase 1 and Industry-sponsored studies within the
Section of Hematology/Oncology within the Department of Pediatrics. The
CRC will be involved in multiple research trial types: multi-centered
cooperative group and intergroup studies at a national level,
multi-institutional pharmaceutical trials, and multi-centered trials
designed, implemented and coordinated in the Section. The Clinical
Research Coordinator 2 works under the general direction of the Director
of Clinical Research and a Senior Clinical Research Coordinator within
the Pediatric Clinical Trials Office, as well as the study PI.
Our department follows a hybrid work structure that fosters
productivity, collaboration, and employee well-being. Working from the
office is encouraged for tasks that require a high degree of
collaboration.
This at-will position is wholly funded by contractual grant funding
which is renewed under provisions set by the grantor of the contract.
Employment will be contingent upon the continued receipt of these grant
funds and satisfactory job performance.
Responsibilities
Manages all aspects of conducting clinical trials including: screening,
enrollment, subject follow-up, completion of the case report form, and
adverse event reports.
Recruit and interview potential study patients with guidance from PI and
other clinical research staff.
Collect, process, ship and store specimens to appropriate laboratory
according to established aseptic techniques.
Identify and explain the responsibilities of Principal Investigators,
research team members, sponsors, contract research organizations (CROs),
and regulatory authorities related to the conduct of a clinical trial.
Coordinate the conduct of the study from startup through closeout
including recruitment and screening of study subjects, obtaining
informed consent, collecting research data, and ensuring protocol
adherence.
Plans and coordinates patient schedule for study procedures, return
visits, and study treatment schedules.
Educates patients about study procedures to be performed, visit
schedule, what to report between and during visits, and the risks and
benefits of the procedures.
Performs assessments at visits and monitors for adverse events.
Organizes and attends site visits from sponsors and other relevant study
meetings.
Protect patients and data confidentiality by e suring security of
research data and personal health information and compliance with
federal regulations and sponsor protocols.
Ensures Standard Operating Procedures (SOP) are implemented and
documented in accordance to study sponsor, primary investigator, and
regulatory agency specifications.
Maintains accurate and complete records which may include, but are not
limited to, signed informed consent, relevant IRB approvals, source
documentation, Case Report Forms (CRF\'s), drug dispensing logs, and
study related communication.
Understand the IRB submission and review process and when and how to
apply for IRB review, including facilitation of study initiation through
meticulous and timely preparation of IRB submissions independently.
Ensures compliance with federal regulations and institutional policies.
May prepare and maintain protocol submissions and revisions.
May assist in the training of new or backup coordinators.
Coordinates and may participate in quality assurance reviews conducted
by study sponsors, federal agencies, or specially designated review
groups.
Analyzes study-related documentation, such as protocol worksheets,
procedural manuals, adverse ev