[ref. a13955721] Clinical Research Coordinator 2 - JR28640-3800 - University of Chicago

apartmentThe University of Chicago placeChicago calendar_month 

This job was posted by https://illinoisjoblink.illinois.gov : For more

information, please see: https://illinoisjoblink.illinois.gov/jobs/12531317 **Department**

BSD MED
  • Hematology and Oncology
  • Clinical Research Staff
  • Cluster 10

**About the Department**

The Section of Hematology/Oncology has a proud and long tradition of
excellence in research-based patient care and clinical discovery. Ranked
among the finest cancer programs in the country, the Section is
comprised of nationally and internationally known faculty with expertise
in all major types of malignancies, blood disorders, and experimental

therapies.

**Job Summary**

The Clinical Research Coordinator 2 (CRC2) is a specialized researcher
partnering with the clinical Principal Investigator (PI) and under the
direction of a departmental or lab research manager. While the Principal
Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC2 supports, facilitates and
coordinates independently the daily clinical trial activities and plays
a critical role in the conduct of the study. By performing these duties

with limited supervision and/or guidance, the CRC2 works with the PI, department, sponsor, and institution to support and provide guidance on

the administration of the compliance, financial, personnel and other

related aspects of the clinical study.

**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.
  • Assist in the training of new or backup coordinators.
  • Analyzes, facilitates and participates in the daily activities of
multiple moderately complex clinical trials and performs a l 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.
  • 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.
  • Accountable for all tasks in moderately complex clinical studies.
  • Performs other related work as needed.

**Minimum Qualifications**

**Education:**

Minimum requirements include a college or university degree in related

field.

**Work Experience:**

Minimum requirements include knowledge and skills developed through 2-5

years of work experience in a related job discipline.

**Certifications:**

**/-/--**

**Preferred Qualifications**

**Education:**
  • Bachelors degree.

**Experience:**

Clinical research experience or relevant experience.

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