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https://illinoisjoblink.illinois.gov/jobs/12666414 Department
BSD MED - Gastroenterology - Clinical Research Staff
About the Department
The Section of Gastroenterology, Hepatology at The University of Chicago
is consistently ranked among the best specialty nationally by U.S News
and World Report. With nearly 30 specialists on staff, our program plays
a leading role in the understanding of digestive diseases and in
developing innovative and successful treatments for patients. Since
forming the nation\'s first full-time department of gastroenterology in
1927, our physicians have continually improved treatments for digestive
tract and related disorders by combining medical research, education,
and patient care at the highest level.
Job Summary
The Clinical Research Coordinator 2 (CRC2) is a specialized researcher,
partnering with the clinical Principal Investigator (PI) and under the
direction of the Clinical Research Manager in the Section of
Gastroenterology in the Department of Medicine.
Responsibilities
Manages all aspects of conducting clinical trials including
screening, enrollment, subject follow-up, completion of the case
report form, and adverse event reports.
Recruits and interviews potential study patients with guidance from
PI and other clinical research staff.
Collects, processes, ships and stores specimens to appropriate
laboratory according to established aseptic techniques.
Identifies and explains the responsibilities of principal
investigators, research team members, sponsors, contract research
organizations (CROs), and regulatory authorities related to the
conduct of a clinical trial.
Coordinates 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.
Protects patients\' and data confidentiality by ensuring 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.
Understands 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.
Responsibilities may include the following non-laboratory duties:
may assist in recruiting and scheduling research subjects; assisting
with developing or amending study protocols; assisting with
developing data collection tools; assisting with building databases;
and providing general administrative support.
Responsibilities may include the following laboratory duties:
setting up and performing experiments; interacting with students and
other laboratory staff under the direction of the principal
investigator.
Analyzes, facilitates and participates in the daily activities of
multiple moderately complex clinical trials and performs all aspects
of clinical data management, including patient data retrieval,
referring MD office records, preparing clinical research charts, and
participation in program audits.
Solves a range of straightforward problems relating to the
administration of the compliance, financial and other related
aspects of a clinical study.
Accountable for all tasks in moderately complex clinical studies.
Facilitates and participates in the daily activities of moderately
complex clinical studies and performs various activities including
patient data retrieval, documenting clinical research records, and
participation in program audits.
Uses knowledge of clinical studies to coordinate the collection of
analyzable clinical research data and/or samples with a limited to
moderate degree of independence. Contributes to the problem solving
on assigned clinical research studies and tasks.
Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include
