Senior Clinical Research Regulatory Coordinator

Intermountain Health

3d • $37 - $59 • Hybrid

About The Position

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

Requirements

• 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
• 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.
• Extensive years of experience in a regulatory research role requiring detailed knowledge of human subject research regulations, strong demonstrated attention to detail and ability to adhere to policies and procedures.

Nice To Haves

• Bachelor's Degree in a clinical or life science field, business, or healthcare operations.
• 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 minimal supervision.
• Actively engages in study design and protocol development for investigator-initiated studies.
• Develop and implement regulatory strategies for clinical trials.
• Prepare and submit regulatory documents, including but not limited to IRB applications, amendments, monitoring reports, and continuing reviews.
• Manage complex regulatory submissions, including IND/IDE applications and international filings.
• Ensure all study activities comply with regulatory requirements and institutional policies.
• 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.
• Prepare for and lead internal and external site visits, audits, and inspections.
• Identify and mitigate regulatory risks associated with clinical trials.
• Maintain accurate and up-to-date records in regulatory databases and tracking systems.
• Organize and maintain both paper and electronic regulatory files and documentation.
• Meet with auditors and monitors to review regulatory files as required.
• 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.
• Professionally manage research relationships with collaborating institutions, investigators, sponsors, and monitors.
• 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.
• Develop and update departmental Standard Operating Procedures (SOPs) for regulatory processes.
• Design and conduct compliance-based training for research team members.
• Review and understand study protocols to ensure compliance with regulatory requirements and guidelines.
• Provide guidance to research staff on regulatory requirements and best practices.
• Assist investigators in writing investigator-initiated protocols.
• Demonstrate the ability to navigate complex issues related to research GCP, HSP, and Intermountain policies.
• Stay informed about changes in regulatory requirements and guidelines.
• Lead and mentor junior regulatory coordinators and research staff.
• Provide direction for the technical, protocol-specific, and operational aspects of assigned trials.
• Guide and support the study team to ensure adherence to study objectives, timelines, and budget.
• Delegate regulatory assignments and assist the Research Director in recruiting and managing regulatory team project workloads, check-ins, and team performance coaching.
• Facilitate and coordinate training, education, and development activities for the team.

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.
• Tuition coverage paid directly to the academic institution for undergraduate studies, high school diplomas, and professional skills and certificates.

What This Job Offers

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