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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.

Duties and Responsibilities, including but not limited to:

• 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

Basic Qualifications:

• Bachelor’s Degree or equivalent required

• 1 year of related experience required

Preferred Qualifications:

• 1 year of clinical trial research experience with active involvement in regulatory affairs preferred

• SOCRA or ACRP certification preferred

Schedule Details:

• Employment Status: Full time (1.0 FTE)

• Weekly Scheduled Hours: 40

• Hours of work: 8:00 a.m. to 5:00 p.m.

• Days worked: Monday to Friday

At BAMF Health, our top priority is patient care. To ensure we are able to drive a Bold Advance Medical Future, we offer a well-rounded benefit package to care for our team members and their families. Highlights include:

• 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

Disclaimer

BAMF Health provides equal opportunities to all employees for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

BAMF Health is an Equal Opportunity Employer and will not accept or tolerate discrimination or harassment against any applicant, employee, intern, or volunteer based upon the following characteristics: race, color, religion, creed, national origin, ancestry, sex, age, qualified mental or physical disability or handicap, sexual orientation, gender identity/expression, transgender status, genetic information, pregnancy or pregnancy-related status, marital status, veteran status, military service, any application for any military service, or any other category or class protected by applicable federal, state, or local laws.