Regulatory Research Coord (IRB Consultant) - Research Affairs

Job Title: Regulatory Research Coord (IRB Consultant) - Research Affairs
Department: Research
Shift: 1st
Specialty: Research
Job Number: 2022-0835
Date Posted: 03/21/2022
Position Type: Research

*Job Qualifications:*

Are you interested in joining a leading health care organization?
Join Rush University Medical Center!
We are seeking a dynamic Research Regulatory Coordinator (IRB Consultant) to join the Office of Research Affairs here at Rush University Medical Center!

This is a Full-Time position
80 hours every two weeks, benefit-eligible

Position Highlights

The Research Regulatory Coordinator 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. The individual who holds this position exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.
Position Responsibilities

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

Position Qualifications Include
Bachelors degree required; Bachelors degree in Health Sciences preferred.
Two or more years of experience working on FDA-regulated clinical trials in the academic or pharmaceutical environment is required.
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.
Requires a commitment to customer service and the ability to work effectively and collaboratively in a complex academic environment.
Requires excellent verbal and written communication skills with a wide range of individuals in a cross-functional environment.
Must be able to work independently with minimal supervision.
Successful candidates can demonstrate proficiency with the Microsoft Office Suite.
VALUES: All Rush staff is expected to:
Continuously develop their skills and knowledge, either through LEAP programs, readings, conferences, departmental training programs or some combination of these.
Develop and display a clear customer service focus at all times.
View their work as part of the larger Rush system, and strive to improve their performance in concert with, rather than in competition with, their co-workers and other Rush employees.
Be conscious of the resources they use in completing their work and to strive to use these resources as efficiently and effectively as possible.
Company Highlights:
Rush's new 14-story hospital is the cornerstone of the Rush Transformation, an ongoing effort to build new facilities, renovate existing buildings and adopt new technology.
Rush University Medical Center is a five-time Magnet facility located in Chicago, IL - www.rush.edu
Leading academic medical center, acute care hospital w/ 676 licensed beds.

Rush is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.