Senior IRB Analyst
Senior IRB Analyst
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Salary Not Disclosed
1 Vacancy
Job Description
At Virtua Health we exist for one reason to better serve you. That means being here for you in all the moments that matter striving each day to connect you to the care you need. Whether thats wellness and prevention experienced specialists lifechanging care or something inbetween we are your partner in health devoted to building a healthier community.
If you live or work in South Jersey exceptional care is all around. Our medical and surgical experts are among the best in the country. We assembled more than 14000 colleagues including over 2850 skilled and compassionate doctors physician assistants and nurse practitioners equipped with the latest technologies treatments and techniques to provide exceptional care close to home. A Magnetrecognized health system ranked by U.S. News and World Report weve received multiple awards for quality safety and outstanding work environment.
In addition to five hospitals seven emergency departments seven urgent care centers and more than 280 otherlocations were committed to the wellbeing of the community. That means bringing lifechanging resources and health services directly into our communities through ourEat Well food access program telehealth home health rehabilitation mobile screenings paramedic programs and convenient online scheduling. Were also affiliated with Penn Medicine for cancer and neurosciences and the Childrens Hospital of Philadelphia for pediatrics.
Location:
Lippincott 301 Lippincott DriveEmployment Type:
EmployeeEmployment Classification:
RegularTime Type:
Full timeWork Shift:
1st Shift (United States of America)Total Weekly Hours:
40Additional Locations:
Job Information:
Job Summary:
Assists the Director of Human Research Protections in ensuring compliance with all federal and state statutes and regulations on protection of human subjects. Able to lead IRB staff and conduct staff training. Represents the IRB through attendance on local committees and IRB meetings support the maintenance of accreditation and conduct initial investigations of study or programmatic noncompliance. Executes and maintains reliance agreements as needed. Serves as a regulatory Subject Matter Expert (SME) for staff students and IRB members on IRB regulations policies and procedures. Provides education as needed.
Position Responsibilities
Assist with the management of daily IRB operations.
Conduct reviews of biomedical and social behavioral research studies in compliance with Federal regulations and Institutional policies and procedures.
- Make an initial determination regarding the necessary level of review.
- Identify issues or concerns that must be addressed to approve the research.
- Make an initial determination regarding the necessary level of review. Identifies issues or concerns that must be addressed to approve the research under the exempt expedited and full board procedures and record review findings in tracking software in a timely manner.
- Serve as reviewer for exempt or expedited reviews.
- Oversight of Reliance Agreements
Work closely with investigators during the review and approval process and advises researchers on regulatory and ethical standards as well as institutional policies and procedures; provides consultation to the research community on submission requirements.
Support the various IRB members by conducting prereviews of requests for modification of previously approved research; requests for continuing approval; potential reportable events; conducting prereviews of responses to initial review; and preparing/contributing to agendas minutes and correspondence.
Assist with the development revision and implementation of policies and procedures to ensure compliance with all applicable regulations policies and guidance.
Participates in IRB quality improvement initiatives including the review of existing IRB policies and procedures the provision of training for IRB administrative staff and other internal QA activities.
Position Qualifications Required:
Required Experience:
A minimum of 5 years experience in clinical research regulatory affairs and human subjects research protection regulations. Detailed knowledge of applicable federal regulations related to IRB and clinical research experience with compliance aspects of regulatory review and oversight.
Previous experience in reviewing human subjects applications
Attention to detail
Excellent interpersonal verbal written and analytical skills Knowledge of medical terminology
Required Education:
Bachelors degree required (Masters Degree preferred) in relevant area (e.g. nursing regulatory science)
Training / Certification / Licensure:
Obtain IRB Professional (CIP) certification within the first year of hire.
Required Experience:
Senior IC
Employment Type
Full-Time
