Research Regulatory Coordinator II

Intermountain Health

4d • Hybrid

About The Position

This position provides subject matter expertise (SME) regarding regulatory research coordination to Intermountain research departments and supports research investigators, managers and directors as needed. The key responsibility of this position is to assure regulatory compliance with the Institutional Review Board (IRB), research sponsors and federal and state regulations pertaining to the protection of human subjects participating in research as according to Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines. This position also oversees or coordinates auditing and monitoring of research studies per required regulations and industry best practices.

Requirements

• Experience in a role requiring effective organizational skills; effective follow-through, and commitment to excellence, effective professional communication skills
• Ability to communicate with others in a clear, understandable, and professional manner as well as strong interpersonal skills
• Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment.
• Demonstrated experience working in a collaborative team environment.
• Experience using word processing, spreadsheet, database, internet and e-mail and scheduling applications.
• Demonstrated years of experience in a research regulatory role.

Nice To Haves

• Bachelor's Degree in a clinical or life science field, business, or healthcare operations. A degree must be obtained through an accredited institution. Education is verified.
• Certified Professional in the field of research or regulatory compliance.
• Experience in a healthcare or hospital setting.

Responsibilities

• Support various research studies and departments across the Intermountain system, typically working on complex or larger research projects with limited supervision.
• Prepare and submit regulatory documents, including IRB applications, amendments, monitoring reports, IRB status reports, and continuing reviews.
• Ensure all study activities comply with regulatory requirements and institutional policies.
• Uses judgment to determine if projects are compliant with federal research regulations and Intermountain policies.
• Contacts and advises study staff and investigators in the preparation and completion of submissions.
• Monitor ongoing studies to ensure compliance with regulatory requirements, report adverse events, protocol deviations, unanticipated problems, and other events per institutional and sponsor reporting policies.
• Prepares for and participates in internal and external site visits, audits and inspections.
• Ensures application(s), study approval(s) and other relevant study documentation and information up to date and in compliance with federal, state and institutional requirements.
• Maintains up to date files (paper and electronic) of all regulatory documents and correspondence.
• Responsible for meeting with auditors and monitors reviewing regulatory files as requested and/or required on an ongoing basis and/or during the conduct of the clinical investigations.
• Communicate effectively with study sites, regulatory bodies, researchers, study teams, IRBs, sponsors, CROs, and other third parties.
• Obtain necessary approvals and documentation.
• Act as a liaison between the research team and regulatory bodies.
• Assist in the training of research staff on regulatory requirements, procedures, and best practices.
• Provide ongoing education on federal policies and regulations impacting human subject’s research.
• Assists and/or develops and updates departmental Standard Operating Procedures (SOPs) for regulatory processes.
• Review and understand study protocols to ensure compliance with regulatory requirements and guidelines.
• Provide guidance to research staff on regulatory requirements and best practices.
• Stays informed about changes in regulatory requirements and guidelines.
• Assist management in developing and executing institutional policies and procedures to ensure compliance with laws and regulations.
• Support study teams with single patient INDs Emergency Use and compassionate use devices, ensuring compliance with FDA requirements.

Benefits

• Comprehensive benefits package that covers a wide range of programs to foster a sustainable culture of wellness that encompasses living healthy, happy, secure, connected, and engaged.
• 100+ learning options to choose from, including undergraduate studies, high school diplomas, and professional skills and certificates.
• Up-front tuition coverage paid directly to the academic institution.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level