Regulatory Assistant – RadioNexus

BAMF Health • Grand Rapids, MI

1d • Onsite

About The Position

Join BAMF Health, where you're not just part of a team; you're at the forefront of a revolution in Theranostics, changing lives for the better. As a member of our global team, you'll contribute to pioneering technology and deliver top-tier patient care. Located in the heart of downtown Grand Rapids, our cutting-edge global headquarters resides within the state-of-the-art Doug Meijer Medical Innovation Building. Step into our modern and spacious facilities, where innovation thrives and collaboration knows no bounds. Join us in our mission to make Theranostics accessible and affordable for all, and be part of something truly remarkable at BAMF Health. The Regulatory Assistant – RadioNexus plays a key role in supporting the day-to-day regulatory operations of clinical trials at BAMF Health and affiliated RadioNexus sites. Responsible for the collection, filing, and organization of regulatory documents and assists with regulatory submissions to the IRB, FDA, and RDRC. Provides direct support to the Start-Up and Regulatory Specialist.

Requirements

• Bachelor’s Degree or equivalent required
• 1 year of related experience required

Nice To Haves

• 1 year of clinical trial research experience with active involvement in regulatory affairs preferred
• SOCRA or ACRP certification preferred

Responsibilities

• Provide regulatory document support for BAMF Grand Rapids studies and RadioNexus network sites, including collection, review, filing, and tracking of required regulatory documents
• Maintain the Investigator Site File (ISF) for assigned studies, including IRB submissions, approvals, correspondence, and all required regulatory and study documents
• Intake, review, process, and track study document updates (amendments, protocol letters, notes to file, Investigator’s Brochures) and prepare submissions to the IRB
• Complete, track, and obtain Investigator and personnel signatures on FDA Form 1572s, Financial Disclosure Forms (FDFs), protocols, amendments, logs, and other study-required documents
• Create, update, and quality-check Delegation of Authority Logs, ensuring accurate staff role assignments and documentation
• Maintain staff training and credential documentation in the ISF (protocol-specific training, EDC, CITI, CVs, licenses) and track document expirations using organized tracking tools
• Perform routine quality control (QC) reviews of regulatory documentation to ensure compliance with GCP, IRB, Sponsor, and FDA requirements; proactively resolve missing or expired items
• Coordinate and assist with monitoring visits and audits, including ISF access, document retrieval, investigator correspondence, and filing of monitor follow-up letters
• Assist with study close-out activities, including quality review, reconciliation, and preparation of ISFs for archiving in accordance with regulatory requirements

Benefits

• Employer paid High Deductible Health Plan with employer HSA contribution
• Flexible Vacation Time
• 401(k) Retirement Plan with generous employer match
• Several benefit options including, but not limited to; dental, vision, disability, life, supplemental coverages, legal and identity protection
• Free Grand Rapids downtown parking

What This Job Offers

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