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Regulatory Coordinator, Cancer and Clinical Trials

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POST DATE 8/13/2016
END DATE 10/22/2016

Rush University Medical Center Chicago, IL

Company
Rush University Medical Center
Job Classification
Full Time
Company Ref #
2016-1723
AJE Ref #
575873225
Location
Chicago, IL
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
JOB DESCRIPTION:

REGULATORY COORDINATOR, CANCER AND CLINICAL TRIALS

The Research Regulatory Coordinator I serves as a key staff member for the regulatory activities of research studies throughout the clinical research life cycle. This individual serves as a subject-matter expert to the research team on issues related to Humans Subjects Protection and Good Clinical Practice.



PRINCIPAL DUTIES AND RESPONSIBILITIES:

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Serves as the primary regulatory contact for assigned protocols
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Completes electronic submissions of the coverage analysis, IRB application, contract, etc. into the Rush Research Portal (RRP).
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Ongoing monitoring of the status of electronic submissions in the RRP.
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Maintains the regulatory binders / files and ensures appropriate version control is in place.
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Writes and prepares regulatory submissions for new project applications, consent forms, drug and device data sheets etc., in accordance with the approved coverage analysis.
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Coordinates submissions to ancillary committees such as Radiation Safety and Institutional Biosafety.
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Communicates with the IRB and Sponsor on behalf of the study team regarding regulatory management.
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Monitors email and sponsor websites to ensure that regulatory documents are up to date and implemented in a timely fashion.
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Communicates with the study team to ensure awareness of protocol changes and process revisions.
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Collaborates with the study team and sponsors to finalize documents based on IRB recommendations.
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Prepares and submits study amendments and continuing review applications for IRB review.
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Prepares reports related to regulatory status for team meetings.
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Ensures timely review and reporting of Unanticipated Problems.
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Prepares regulatory files for auditing and monitoring visits.
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Updates databases for reporting requirements.
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May serve as a protocol coordinator, when needed.
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Performs additional duties as assigned.



KNOWLEDGE, SKILLS AND ABILITIES:

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Bachelor s degree required; Bachelor s degree in Health Sciences preferred.
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Two or more years of experience working on FDA-regulated clinical trials in the academic or pharmaceutical environment is required.
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Must demonstrate proficiency with the Code of Federal Regulations pertaining to Human Subject Protections, including 45CFR46, 21CFR50 and 56, Good Clinical Practice, the Declaration of Helsinki, the Belmont Report, and HIPAA.
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Requires a commitment to customer service and the ability to work effectively and collaboratively in a complex academic environment.
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Requires excellent verbal and written communication skills with a wide range of individuals in a cross-functional environment.
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Must be able to work independently with minimal supervision.
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Successful candidates can demonstrate proficiency with the Microsoft Office Suite.



RUSH HIGHLIGHTS:

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Ranked among the top academic medical centers in the country, Rush University Medical Center is an outstanding place to enhance your career. Everything we do centers on one goal: improving patient care.
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Rush's 14-story medical hospital building, the Tower, is the cornerstone of the Rush campus transformation, and is the symbol of a philosophy - an evolution in the delivery of patient-centered care.
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Rush University Medical Center is a four time Magnet facility located in Chicago, IL - www.rush.edu
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Preeminent academic medical center, acute care hospital w/ 676 licensed beds.
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Rush University is home to one of the first medical colleges in the Midwest and one of the nation's top-ranked nursing colleges, as well as graduate



RUSH UNIVERSITY MEDICAL CENTER IS AN EQUAL OPPORTUNITY EMPLOYER THAT WELCOMES AND ENCOURAGES ALL APPLICANTS TO APPLY REGARDLESS OF AGE, RACE, SEX, RELIGION, COLOR, NATIONAL ORIGIN, DISABILITY, VETERAN STATUS, SEXUAL ORIENTATION, GENDER IDENTITY AND/OR EXPRESSION, MARITAL OR PARENTAL STATUS, ANCESTRY, CITIZENSHIP STATUS, PREGNANCY OR OTHER REASON PROHIBITED BY LAW. *LI-MK1