The IRB Analyst II will coordinate and attend all IRB and Executive Committee meetings; assist research investigators and study coordinators in the processing of research proposals; review and track new protocol submissions, amendments, adverse event reports, and progress reports; prepare and distribute review materials, and agendas and minutes of IRB meetings to all IRB members; generate correspondence to investigators based on determinations made by and assigned expedited reviewer or the Board... more details
IRB Analyst II
LocationUS-NJ-Camden
Job ID
18726
Category
Professionals
Shift
1
Type
Full Time
Department Name
Human Research Protections Program E and R Building
About Us
At Cooper University Health Care, our commitment to providing extraordinary health care begins with our team. Our extraordinary professionals are continuously discovering clinical innovations and enhanced access to the most up-to-date facilities, equipment, technologies and research protocols. We have a commitment to its employees by providing competitive rates and compensation, a comprehensive employee benefits programs, attractive working conditions, and the chance to build and explore a career opportunity by offering professional development.
Discover why Cooper University Health Care is the employer of choice in South Jersey.
Short Description
The IRB Analyst II will coordinate and attend all IRB and Executive Committee meetings; assist research investigators and study coordinators in the processing of research proposals; review and track new protocol submissions, amendments, adverse event reports, and progress reports; prepare and distribute review materials, and agendas and minutes of IRB meetings to all IRB members; generate correspondence to investigators based on determinations made by and assigned expedited reviewer or the Board; distribute research protocols to administration for review and signatures; notify investigators about impending study expiration; manage and maintain the online electronic system and study files (online and/ or paper) that document protocol activity; provide guidance and consultation to IRB members and investigators regarding implementation of federal regulations, state law, and Cooper IRB policies and procedures; and assist the IRB Manager and the IRB Chairs with special assignments.
• Excellent written and oral communication skills.
• Excellent time management skills.
• Ability to work as an effective team member.
• Ability to provide excellent customer service.
• Familiarity with MS Office programs and MS Windows operating system required.
• Familiarity with iMedRIS preferred.
• Certification as an IRB Professional (CIP) preferred.
Experience Required
Knowledge of the Common Rule (45 CFR 46), FDA regulations, ICH Good Clinical Practice Guidelines, and other relevant requirements and guidelines related to the ethical study of human research subjects.
Education Requirements
A Bachelor’s degree in an appropriate field or an equivalent combination of education and experience.
Minimum of 2 years of experience in IRB administration, clinical research, or regulatory compliance with human subjects.
Refer this job to a friend
Cooper University Health Care is an Equal Opportunity Employer and is committed to equal employment opportunity for all team members. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, or any other status protected by law or regulation. To request reasonable accommodation, contact HRRecruitment@CooperHealth.eduViewApply StartCompleted
Job Abstracts is an independent Job Search Engine. Job Abstracts is not an agent or representative and is not endorsed, sponsored or affiliated with any employer. Job Abstracts uses proprietary technology to keep the availability and accuracy of its job listings and their details. All trademarks, service marks, logos, domain names, and job descriptions are the property of their respective holder. Job Abstracts does not have its members apply for a job on the jobabstracts.com website. Additionally, Job Abstracts may provide a list of third-party job listings that may not be affiliated with any employer. Please make sure you understand and agree to the website's Terms & Conditions and Privacy Policies you are applying on as they may differ from ours and are not in our control.
Welcome to Job Abstracts
We would like to take a second to Welcome You to Job Abstracts, the nation’s largest Pure Job Board. With over 3.1 million job listings from 15,000+ Companies & Organizations, we help job searchers find careers that match their interests. As an anonymous user, you have probably discovered how easy our system is to use. However, you have just scratched the surface of what we can offer.
We encourage you to Register so you can use our most powerful features: searching with multiple terms, setting up multiple locations, establishing favorite companies, and accessing your search history. If you find a job you like, you can apply directly for it, and then, keep notes on it. We will also keep a lookout for jobs that match your search terms and email you when we find something you may like.
You can register for free and the system is free to use. If you like our system so far, click on Register and unlock the power required by serious job searchers.
Any time you conduct a search, the system shows you job matches, ranked by their Relevance Score (RS).
The score is calculated by a proprietary algorithm that uses Intelligent Machine Learning.
The Relevance Score tells you how well the job opportunity matches your search term or terms.
When not logged in, the system is limited to one search term. Scores for single term matches are usually lower.
When you register, log in, and set up multiple terms prioritized by importance, the jobs found for you will receive a much higher Relevance Score.