Clinical Research Regulatory Specialist

Memphis, TN - USA

Monthly Salary: Not Disclosed

Posted on: 5 days ago

Vacancies: 1 Vacancy

Job Summary

Full-time

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:

Bachelors 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
Masters 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

#SMF

Required Experience:

Full-timeDescriptionThe 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 tal...