Job Description

Job Title:
Clinical Regulatory Research Coordinator 2 - Research Affairs
Department:
Shift:
1st
Full/Part:
Active Regular FT (72 to 80 hours per pay period)
Specialty:
Research
Job Number:
2019-2281
Job Description:
At Rush University Medical Center, we are committed to advancing scientific medical knowledge through research. We are revitalizing our medical centers with an emphasis on productivity, transparency and accountability. Are you looking to be a part of the exciting, always evolving and expanding new developments in research here at Rush University Medical Center? Are you well experienced in working with a variety of group, single and industry oriented studies?
If this describes you, you may be the right candidate for the Clinical Regulatory Research Coordinator 2 position with the Office of Research Affairs at Rush University Medical Center.
Position Summary :
The Research Regulatory Coordinator II 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 :
+ Bachelor’s degree required; Bachelor’s 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.
Company Highlights :
+ 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.
+ The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has awarded Rush full accreditation for three years. Rush is one of the first academic medical centers in Illinois to receive this accreditation.
+ As an academic medical center, Rush University Medical Center in Chicago, Illinois, is committed to advancing medical knowledge through research. Investigators at Rush are involved in more than 1,600 projects, including hundreds of clinical studies to test the effectiveness and safety of new therapies and medical devices, as well as to expand scientific and medical knowledge.
+ RUMC offers a competitive salary, outstanding benefits & the professional advantages of an environment that supports y
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