Research Regulatory Specialist

Research Regulatory Specialist

Inspired by faith. Driven by innovation. Powered by humankindness. CommonSpirit Health is building a healthier future for all through its integrated health services. As one of the nation's largest nonprofit Catholic healthcare organizations, CommonSpirit Health delivers more than 20 million patient encounters annually through more than 2,300 clinics, care sites and 158 hospital-based locations, in addition to its home-based services and virtual care offerings.

As our Research Regulatory Specialist, you will play a pivotal role in advancing cutting-edge clinical studies. We are seeking a meticulous and detail-oriented professional with a passion for clinical research and regulatory compliance.

Every day you will coordinate and participate in clinical research studies, ensuring seamless operations from start to finish. You'll be responsible for the meticulous collection, documentation, and reporting of vital clinical research data, contributing directly to program management and grant funding success.

To be successful in this role, you will be responsible for study coordination, schedule subject study visits, ensuring adequate supplies, procedures, and investigator availability. Provide study-specific, individualized education to study subjects and their families. Ensure all appropriate subject consents are obtained. Collect and process protocol-required specimens. Act as a crucial liaison between the Sponsor, Investigator, and Study Subject. Data Management & Reporting: Collect all required study data and complete CRFs (Case Report Forms) in a timely and accurate manner. Prepare comprehensive project reports related to program management and grant funding. Regulatory Compliance & Quality Assurance: Ensure study documents are maintained in strict compliance with applicable regulations, guidelines, and policies (e.g., FDA, OHRP, IRB). Collaborate closely with investigators to identify adverse events and serious adverse events, ensuring subject safety and accurate, timely reporting. Demonstrate exceptional internal and external customer service through professional interactions with Sponsors, study monitors, and internal departments. Comply with all regulatory and policy requirements. Maintain and apply deep knowledge of federal and state regulations, guidelines, and policies governing the conduct of clinical trials.

Required: Associate's degree in a related field OR an equivalent combination of relevant education and job-related experience in lieu of a degree Minimum of Two (2) years of related experience in clinical research or regulatory affairs Competency in computer skills, including strong proficiency with Microsoft Office products (Word, Excel, Outlook, PowerPoint) Proven ability to coordinate and manage multiple tasks with high attention to detail Strong understanding of clinical trial processes and regulatory requirements (FDA, OHRP, IRB) Excellent written and verbal communication skills, including the ability to educate subjects and families effectively Proficiency in data collection and reporting Exceptional organizational and time management abilities Ability to work independently and as part of a collaborative team

Preferred: Bachelor's degree in a related field Three (3)+ years of clinical experience

Hello Humankindness

Imagine working in an environment where your experience and dedication truly makes a difference, guided by Dignity Health's profound values: Dignity, Justice, Stewardship, Collaboration, and Quality. Here, patient-first care isn't just a motto – it's our daily practice. As a leading 443-bed acute care hospital, we champion interdisciplinary teamwork and the highest standards of safety, because our patients, and you, deserve nothing less.

For over 50 years, Chandler Regional Medical Center (CRMC) has been a trusted partner to the vibrant East Valley community. This means you'll be joining a stable, growing organization with a rich history of service and innovation. We're passionate about your professional growth, offering extensive training, comprehensive resources, and abundant career advancement opportunities to help you reach your full potential.

If you're a dedicated, compassionate professional eager for a dynamic, patient-centered career with one of Arizona's 'Most Admired Companies,' and you thrive in a truly supportive environment, we invite you to discover how your passion can transform lives at CRMC. Explore our opportunities and become a part of a team that celebrates you.