Highmark Health
Research Compliance Specialist Senior
Highmark Health, Greendale, Wisconsin, United States, 53129
Pittsburgh PA, 4 Allegheny Center, Pittsburgh
Ensures compliance with federal regulations, state laws and institutional guidelines throughout the review and approval process of all research involving human subjects.ESSENTIAL RESPONSIBILITIES:Manages work flow processes and conducts activities pertaining to IRB review and approval for protocols involving human subjects submitted by researchers; monitors the protocol review process to ensure complete and expedient review of all protocols and ensures all special regulatory issues have been properly addressed and approvals/authorizations obtained. (20%)Provides direction and advice to researchers involving human subject research protocols regarding submission, completeness/accuracy, informed consent documentation, amendments, continuing review protocols and adverse events submission; reviews submitted protocols for exempt or expedited review and approval. (20%)Guides and advises IRB staff, investigators, research teams, hospital administrators and staff regarding regulations and compliance activities as they pertain to clinical research of human subjects; administers Adverse Event Committee and IRB Committee meetings, including minute taking. (20%)Assists with compliance to all federal regulations, institutional policies and procedures, guidelines and state law in IRB files and protocols; assists in the development of policies and procedures. (20%)Assists with the educational sessions with researchers and study coordinators, oversees the management of the IRB database and completes other duties as assigned. (20%)Other duties as assigned.QUALIFICATIONS:Minimum:Bachelor’s degree in health-related field or relevant experience and/or education as determined by the company in lieu of bachelor's degree5 years IRB or clinical research experienceWorking knowledge and understanding of scientific and medical conceptsAdvanced understanding and application of theoretical knowledge of research compliance as it relates to human subject research and IRB functionsDisclaimer:
The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job.Compliance Requirement:
This job adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies.
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Ensures compliance with federal regulations, state laws and institutional guidelines throughout the review and approval process of all research involving human subjects.ESSENTIAL RESPONSIBILITIES:Manages work flow processes and conducts activities pertaining to IRB review and approval for protocols involving human subjects submitted by researchers; monitors the protocol review process to ensure complete and expedient review of all protocols and ensures all special regulatory issues have been properly addressed and approvals/authorizations obtained. (20%)Provides direction and advice to researchers involving human subject research protocols regarding submission, completeness/accuracy, informed consent documentation, amendments, continuing review protocols and adverse events submission; reviews submitted protocols for exempt or expedited review and approval. (20%)Guides and advises IRB staff, investigators, research teams, hospital administrators and staff regarding regulations and compliance activities as they pertain to clinical research of human subjects; administers Adverse Event Committee and IRB Committee meetings, including minute taking. (20%)Assists with compliance to all federal regulations, institutional policies and procedures, guidelines and state law in IRB files and protocols; assists in the development of policies and procedures. (20%)Assists with the educational sessions with researchers and study coordinators, oversees the management of the IRB database and completes other duties as assigned. (20%)Other duties as assigned.QUALIFICATIONS:Minimum:Bachelor’s degree in health-related field or relevant experience and/or education as determined by the company in lieu of bachelor's degree5 years IRB or clinical research experienceWorking knowledge and understanding of scientific and medical conceptsAdvanced understanding and application of theoretical knowledge of research compliance as it relates to human subject research and IRB functionsDisclaimer:
The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job.Compliance Requirement:
This job adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies.
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