Assistant Director, Institutional Review Board - Long Branch, NJ

RWJBarnabas Health•Long Branch, NJ

42d

About The Position

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. Perform 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; instruct IRB Chairs, members, and researchers on the regulations and ethical principles essential to the review process; provide training and advice to faculty, staff, and student researchers on the regulations and preparation of applications and consent forms. Review and approve administrative and procedural modifications of applications. Responsible for reporting identified safety issues such as hazardous environments (i.e. damaged floors/walls/ceiling tiles/unsecured areas), medical errors, and patient safety concerns.

Requirements

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 Data Base associated with IRB Standards

Nice To Haves

Bachelor's Degree

Responsibilities

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; ensuring 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
Facilitate and maintain IRB Accreditation for Monmouth Medical Center, Monmouth Medical Center Southern Campus, Behavioral Health and Rahway Hospital. Serve as point of contact on IRB-related issues
Interpret and apply federal and state laws, regulations, institutional policies and guidelines to protect human subjects and to 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