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RWJBarnabas Health

Assistant Director, Institutional Review Board - Long Branch, NJ

RWJBarnabas Health, Long Branch, New Jersey, us, 07740

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Assistant Director, Institutional Review Board - Long Branch, NJ

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RWJBarnabas Health Job Information

Req #:

0000197806 Category:

Laboratory and Medical Technologist Status:

Full-Time Shift:

Day Facility:

Monmouth Medical Center Department:

Institutional Review Board Pay Range:

$102,960.00 - $128,960.00 per year Location:

300 Second Avenue, Long Branch, NJ 07740 Responsibilities

Job Overview: Works with the Chief Academic Officer, Director of Clinical Trials and the Clinical Research staff of various departments within Monmouth Medical Center and will manage the privileged and confidential institutional review and approval process of all proposed research activities involving human subjects to protect their safety, rights and welfare. Performs highly complex duties to facilitate the review and approval process, such as the use of independent judgment in interpreting and applying relevant federal and state laws, regulations and institutional policies and guidelines. Instructs IRB Chairs, members, and researchers on the regulations and ethical principles essential to the review process; provides training and advice to faculty, staff, and student researchers on the regulations and preparation of applications and consent forms. Reviews and approves administrative and procedural modifications of applications. Responsible for reporting identified safety issues such as hazardous environments, medical errors, and patient safety concerns. Essential Functions: Analyzes all protocol submissions for completeness and accuracy, recommending the appropriate level of IRB review in accordance with federal and institutional codes, rules and regulations governing biomedical research; ensures that all IRB activities and documents are in compliance with OHRP and FDA regulations. Attends local and national conferences and seminars and other research-related meetings as requested by the Chair and Senior Research Administrator to keep abreast of regulatory and legislative requirements related to research. Facilitates and maintains IRB Accreditation for Monmouth Medical Center, Monmouth Medical Center Southern Campus, Behavioral Health and Rahway Hospital. Serves as point of contact on IRB-related issues. Interprets and applies federal and state laws, regulations, institutional policies and guidelines to protect human subjects and ensure institutional compliance by providing regulatory, ethical, and methodological advice to investigators, staff, residents and students in preparing applications for research proposals involving human subjects as needed or required. Monitors, analyzes and transmits information to the IRB and investigators on new and/or modified protocols for proper review and conduct of clinical research. Qualifications

Required: Associate's Degree 3 years of experience related to clinical research or research administration Ability to obtain professional IRB Certification Knowledge of state and federal regulations governing the ethical conduct of research and protection of human subjects Demonstrate knowledge and understanding of IRB regulations and ICH/GCP guidelines Comprehensive knowledge of medical terminology preferred Excellent verbal and written communication skills Computer literacy: Microsoft Word, Excel, PowerPoint, knowledge of database associated with IRB Standards Preferred: Bachelor's Degree Scheduling Requirements

Full-Time Day Shift 40 hours per week Benefits and Perks

At RWJBarnabas Health, our market-competitive Total Rewards package provides comprehensive benefits and resources to support our employees’ physical, emotional, social, and financial health. Paid Time Off (PTO) Medical and Prescription Drug Insurance Dental and Vision Insurance Retirement Plans Short & Long Term Disability Life & Accidental Death Insurance Tution Reimbursement Health Care/Dependent Care Flexible Spending Accounts Wellness Programs Voluntary Benefits (e.g., Pet Insurance) Discounts Through our Partners such as NJ Devils, NJ PAC, Verizon, and more Equal Opportunity Employer RWJBarnabas Health is an Equal Opportunity Employer

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