Regulatory Assistant - Grand Rapids - Bamf Health

    Bamf Health
    Bamf Health Grand Rapids

    1 week ago

    Description

    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.
    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.
  • Work in company

    Regulatory Assistant – RadioNexus

    Only for registered members

    Join BAMF Health in our mission to make Theranostics accessible and affordable for all. As a Regulatory Assistant – RadioNexus, you'll support the day-to-day regulatory operations of clinical trials and assist with regulatory submissions. · Bachelor's Degree or equivalent require ...

    Grand Rapids

    1 week ago

  • Work in company

    Regulatory Assistant – RadioNexus

    Only for registered members

    Join BAMF Health in a revolutionary Theranostics mission to make treatments accessible and affordable for all. · Support day-to-day regulatory operations of clinical trials at BAMF Health and affiliated RadioNexus sites. · ...

    Grand Rapids, MI

    3 weeks ago

  • Work in company

    Regulatory Assistant – RadioNexus

    Only for registered members

    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. · Support regulatory operations for clinical trials at BAMF Health and affiliated RadioNexus sites. · ...

    Grand Rapids Full time

    3 weeks ago

  • Work in company

    FSQA Regulatory

    Only for registered members

    We are seeking a detail-oriented FSQA Regulatory & Systems Specialist to join our Food Safety and Quality Assurance team. · Support regulatory compliance & documentation · • Labeling oversight: support development, review, & approval of product labels to ensure compliance with US ...

    Grand Rapids

    1 month ago

  • Work in company

    Environmental, Health,

    Only for registered members

    +As an Intern, in Health, Safety & Environment (HS&E), your role would be to support the plant's efforts to maintain a safe, healthy, and environmentally responsible workplace, ensuring compliance with regulations, and fostering a culture of safety and sustainability among employ ...

    Grand Rapids $17.75 - $21 (USD)

    1 day ago

  • Work in company

    Controller

    Only for registered members

    WMCU is seeking a detail-oriented and strategic Controller to lead our accounting operations and ensure financial integrity across the organization. · ...

    Grand Rapids

    1 month ago

  • Work in company

    Trade Compliance Research and Advisory Analyst

    Only for registered members

    We're seeking a research-driven Trade Compliance Research & Advisory Analyst to support complex customs and regulatory inquiries. · Research and interpret U.S. Customs regulations, · ...

    Grand Rapids

    1 week ago

  • Work in company

    Senior Regulatory Consultant

    Only for registered members

    The Senior Regulatory Consultant provides strategic support and ownership of the · Regulatory processes for Customer Experience and Operations including Energy Waste Reduction filings, · Demand Response Filings, Voluntary Green Pricing filings, Renewable Natural Gas Filings, gen ...

    Grand Rapids

    3 weeks ago

  • Work in company

    Travel Pathology Assistant

    Only for registered members

    We are seeking a Travel Pathology Assistant. Assist with specimen processing and maintain laboratory cleanliness and safety protocols. · ...

    Grand Rapids

    1 month ago

  • Work in company

    Travel MRI Technician

    Only for registered members

    We are seeking a Travel MRI Tech to join our team in Alpena, MI. · technical proficiency in MRI operationstrong attention to detailexcellent communication ...

    Grand Rapids

    1 month ago

  • Work in company

    Master Planner

    Only for registered members

    We're looking for talent to develop and execute integrated planning strategies that ensure efficient and compliant production of transdermal pharmaceutical products. · ...

    Grand Rapids

    1 week ago

  • Work in company

    Travel Physical Therapist

    Only for registered members

    We are seeking a dedicated and skilled travel physical therapist for a rewarding opportunity in West Branch MI near Grand Rapids. The ideal candidate will have excellent clinical skills and be able to work effectively with diverse patient populations. · ...

    Grand Rapids

    1 month ago

  • Work in company

    Site EHS Director

    Only for registered members

    + Site EHS Director + · Job summary: We have been retained by a FORTUNE 500 manufacturing based organization who is actively seeking a Senior level E+ · Responsibilities: Lead and direct personnel and strategy for Health and Safety programs. · Ensure campus wide awareness/culture ...

    Grand Rapids

    2 weeks ago

  • Work in company

    Travel Physical Therapist

    Only for registered members

    +Travel Physical Therapist to join our team in Alpena, MI with weekly pay ranging from $2, 62 to $2,0262. · + · +Assess plan and implement individualized treatment programs for diverse patient populations.Collaborate with healthcare teams to optimize patient recovery and mobility ...

    Grand Rapids

    1 month ago

  • Work in company

    Locum Physician

    Only for registered members

    Seeking a dedicated Locum Physician (MD/DO) in Neurology for a hospital in Grand Rapids Michigan. Provide comprehensive neurological assessments diagnoses and treatment plans for diverse patient cases. Collaborate with healthcare teams to ensure high-quality patient care and safe ...

    Grand Rapids

    1 month ago

  • Work in company

    Travel Physical Therapist

    Only for registered members

    +Seeking a dedicated Travel Physical Therapist (PT) in Livonia MI offering competitive pay flexible assignments and health insurance options. · +Assess plan and implement individualized treatment programs for diverse patient populations. · Collaborate with healthcare teams to ens ...

    Grand Rapids

    1 month ago

  • Work in company

    Travel Occupational Therapist

    Only for registered members

    Seeking a dedicated Travel Occupational Therapist (OT) in Adrian MI near Grand Rapids to provide skilled occupational therapy services to patients in various clinical settings Assess patient needs develop personalized treatment plans and monitor progress Collaborate with healthca ...

    Grand Rapids

    1 month ago

  • Work in company

    Travel Physical Therapist

    Only for registered members

    Seeking a dedicated Travel Physical Therapist (PT) for West Branch, MI near Grand Rapids. · ...

    Grand Rapids $1,814 - $2,011 (USD)

    1 month ago

  • Work in company

    Travel Occupational Therapist

    Only for registered members

    We are seeking a Travel Occupational Therapist to provide exceptional therapy services in Houghton Lake, MI. · ...

    Grand Rapids

    1 month ago

  • Work in company

    Locum Physician

    Only for registered members

    Seeking a dedicated Locum Physician (MD/DO) in Obstetrics and Gynecology to provide high-quality care in Detroit, MI. · Perform comprehensive women's health exams. · Prenatal and postpartum care. · ...

    Grand Rapids

    1 month ago

  • Work in company

    Locum Physician

    Only for registered members

    We are seeking a dedicated Locum Physician (MD/DO) specializing in Hematology and Oncology in Grand Rapids, MI. · We provide comprehensive hematology and oncology patient care including diagnosis treatment and follow-up. Provide comprehensive hematology and oncology patient care ...

    Grand Rapids

    1 month ago

Jobs
>
Regulatory assistant
>
Jobs for Regulatory assistant in Grand Rapids