Company: Indiana University
Posted on: February 15, 2020
Department CANCER CENTER (IN-CANC-IUINA) Department Information
The mission of the IU Simon Cancer Center ( IUSCC ) Clinical Trials
Office ( CTO ) is to support and facilitate the conduct of quality
clinical research by IUSCC translational clinical investigators.
The CTO is a centralized resource available to all clinical
investigators of the IU Simon Cancer Center whose services enable
the safe and efficient conduct of adult and pediatric trials. The
CTO assists in protocol development, IND / IDE management and
coordinates the scientific review of proposed trials by the
Protocol Review and Monitoring System ( SRC ) of the cancer center.
Job Summary The IU Simon Cancer Center's Clinical Trials Office is
currently seeking a Quality Assurance Coordinator. This position
will provide leadership for research operations and the conduct of
research studies in accordance with FDA guidelines, GCP and SOPs.
Primary areas of responsibilities focus on staff education,
internal monitoring, quality assurance, and process improvement.
Specifically, this position will monitor and/or audit studies,
assess for accuracy and completeness of the CRF entries, source
documents, and other trial-related records, and ensure compliance
to protocol as well as SOPs. The coordinator will use the findings
as retraining tools in order to clarify processes, best practices,
GCPs and protocol compliance. Required Qualifications Bachelor's
degree in science or health-related field and two years of
experience in clinical research; OR associate's degree in Allied
Health professions/bachelor's degree in other disciplines and three
years of experience in clinical research. Additionally, six months
of clinical research experience as a Clinical Research Specialist
within the IU Simon Cancer Center's Clinical Trials Office OR
twelve months of clinical research monitoring experience outside of
the IUSCC Clinical Trials Office is also required and may be
obtained concurrently. Clinical Research Certification ( ARCP or
SOCRA ). Ability to effectively communicate and exchange
information. Preferred Qualifications Clinical research monitoring
experience. Work Location IUPUI CampusCancer Pavilion, Clinical
Trials OfficeIndianapolis, Indiana Job Classification Salary Plan:
PAESalary Grade: 3RSFLSA: ExemptJob Function: Research Posting
Disclaimer This posting is scheduled to close at 11:59pm EST on the
advertised Close Date. This posting may be closed at any time at
the discretion of the University, but it will remain open for a
minimum of 5 business days. To guarantee full consideration, please
submit your application within 5 business days of the Posted Date.
Equal Employment Opportunity Indiana University is an equal
employment and affirmative action employer and a provider of ADA
services. All qualified applicants will receive consideration for
employment without regard to age, ethnicity, color, race, religion,
sex, sexual orientation, gender identity or expression, genetic
information, marital status, national origin, disability status or
protected veteran status. Indiana University does not discriminate
on the basis of sex in its educational programs and activities,
including employment and admission, as required by Title IX.
Questions or complaints regarding Title IX may be referred to the
U.S. Department of Education Office for Civil Rights or the
university Title IX Coordinator. See Indiana University's Notice of
Non-Discrimination here which includes contact information.
Keywords: Indiana University, Bloomington , Accounting Associate, Accounting, Auditing , Bloomington, Indiana
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