Clinical Research Regulatory Specialist
Semmes Murphey, Memphis, TN, United States
Description
The Semmes Murphey Foundation, affiliated with Semmes Murphey Clinic, is an independent, research-focused, public benefit corporation (501(c)3) dedicated to advancing innovation and excellence in neuroscience. We are growing our clinical research department and looking to add new talent to our team.
This role provides our Foundation with critical regulatory support across various industry-sponsored clinical trials, PI-initiated and grant-funded studies, and quality registries. You will ensure regulatory compliance, timely IRB submissions, document control, and audit-ready study files throughout the lifecycle of clinical research projects.
Essential Duties and Responsibilities
Prepare, submit, and track IRB applications for new studies, amendments, continuing reviews, and study closures
Serve as a regulatory resource for investigators and research staff; assist with regulatory education and SOP adherence
Facilitate contract and budget administration by coordinating IRB, sponsor organizations, physicians, outside counsel, and internal staff to keep projects on track
Maintains regulatory binders and essential documents in compliance with FDA, CFR, ICH-GCP, HIPAA, and institutional policies
Support internal audits, sponsor monitoring visits, and regulatory inspections; maintain audit-ready files
Assist with data reporting, electronic data entry, and administrative study tasks as required by protocol
Support quality initiatives and regulatory process improvements in collaboration with the Clinical Research Manager
Requirements
MINIMUM:
Bachelor's degree in health sciences, life sciences, public health, healthcare administration, or related field
Two or more years of clinical research experience; preferably with demonstrated regulatory and IRB submission responsibilities
PREFERRED:
Five plus years of clinical research regulatory experience
Master's degree in related field
Professional certifications such as CCRC (ACRP) or CCRP (SOCRA)
Experience supporting multi-site or industry-sponsored clinical trials
Additional required skills include a working knowledge of FDA regulations (e.g. 21 CFR Parts 50, 54, 56, and 312/812 as applicable), the clinical trial process, and ICH-GCP guidelines. This role requires strong organizational skills and a high attention to detail.
Equal Opportunity Employer/Veterans/Disabled
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The Semmes Murphey Foundation, affiliated with Semmes Murphey Clinic, is an independent, research-focused, public benefit corporation (501(c)3) dedicated to advancing innovation and excellence in neuroscience. We are growing our clinical research department and looking to add new talent to our team.
This role provides our Foundation with critical regulatory support across various industry-sponsored clinical trials, PI-initiated and grant-funded studies, and quality registries. You will ensure regulatory compliance, timely IRB submissions, document control, and audit-ready study files throughout the lifecycle of clinical research projects.
Essential Duties and Responsibilities
Prepare, submit, and track IRB applications for new studies, amendments, continuing reviews, and study closures
Serve as a regulatory resource for investigators and research staff; assist with regulatory education and SOP adherence
Facilitate contract and budget administration by coordinating IRB, sponsor organizations, physicians, outside counsel, and internal staff to keep projects on track
Maintains regulatory binders and essential documents in compliance with FDA, CFR, ICH-GCP, HIPAA, and institutional policies
Support internal audits, sponsor monitoring visits, and regulatory inspections; maintain audit-ready files
Assist with data reporting, electronic data entry, and administrative study tasks as required by protocol
Support quality initiatives and regulatory process improvements in collaboration with the Clinical Research Manager
Requirements
MINIMUM:
Bachelor's degree in health sciences, life sciences, public health, healthcare administration, or related field
Two or more years of clinical research experience; preferably with demonstrated regulatory and IRB submission responsibilities
PREFERRED:
Five plus years of clinical research regulatory experience
Master's degree in related field
Professional certifications such as CCRC (ACRP) or CCRP (SOCRA)
Experience supporting multi-site or industry-sponsored clinical trials
Additional required skills include a working knowledge of FDA regulations (e.g. 21 CFR Parts 50, 54, 56, and 312/812 as applicable), the clinical trial process, and ICH-GCP guidelines. This role requires strong organizational skills and a high attention to detail.
Equal Opportunity Employer/Veterans/Disabled
#J-18808-Ljbffr