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1 Vacancy
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.
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
Full-Time