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Regulatory Compliance Officer Job Opening In Columbus – Now Hiring The Ohio State University


Job description

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  • Job Title:

    Regulatory Compliance Officer

    Department:

    Medicine | Clinical Trials Management Office Earnings

    Regulatory Compliance Officer who provides regulatory expertise to assure research protocols are in compliance with university, state and federal regulations across research groups managed by the College of Medicine Center for Clinical Research Management (CCRM); participates in development and implementation of strategies, policies and procedures to ensure proposals meet or exceed federal, state and local regulations; develops and prepares protocol submissions to local and national Institutional Review Boards (IRB), including writing of abstract, submission of standard forms and drafting of informed consent form; collaborates with investigators during study development to facilitate and confirm that appropriate regulatory safeguards have been included; conducts detailed reviews of assigned protocols and informed consent forms prior to IRB review; ensures timely submission of protocol documents for review by appropriate agency; communicates with sponsors of any research project (industry, federal, collaborative, investigator-initiated) to address concerns and assure compliance; establishes and oversees tracking system to continually monitor progress of protocol review and status of approval; reviews and authorizes protocol revisions and amendments; amends consent forms as needed and follows established guidelines from OSU and NIH (National Institutes of Health) to determine if amendment requires IRB review; distributes amendments and IRB approved informed consent forms to relevant university protocol holders; continually monitors federal and sponsor rules, regulations and processes to identify and interpret new, updated or changed requirements; provides regulatory updates to investigators and research staff of new or changed regulations; participates in audits and site visits.


    Minimum Education Required
    Bachelor's Level Degree or equivalent combination of education and experience.


    Required Qualifications
    2 years of relevant experience in a clinical research or administrative capacity working on clinical research projects required; considerable knowledge of clinical research regulations and compliance issues especially related to the use of human and animal subjects required.

    Desired Qualifications

    2-4 years of relevant experience preferred.

    Experience and knowledge of federal & industry research sponsor requirements preferred; experience in a regulatory affairs capacity in a medical research setting desired; experience in protocol development desired.

    Explore our extensive benefits

    .

    Work-life: Flexible and remote work arrangement opportunities where applicable, childcare program, and access to educational, athletic and cultural events.

    Retirement: State pension and alternative options with competitive employer contributions, as well as optional supplemental plans.

    Health: Medical, dental, vision and prescription coverage, life insurance, flexible spending accounts and wellness programming.

    Time off: Paid vacation and sick time, parental and medical leave plus 11 paid holidays.

    Short and long-term disability options also available.

    Financial: Tuition assistance for employees and their dependents, adoption assistance and discounts with preferred vendors and university partners.

    Wellness: Lifestyle spending account, employee assistance program, health reimbursement account, and employee wellness program.

    Required Skill Profession

    Business Operations Specialists


    • Job Details

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    Unlock Your Regulatory Compliance Potential: Insight & Career Growth Guide


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    111 Jobs in Columbus
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    The Work Culture

    An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at The Ohio State University adheres to the cultural norms as outlined by Expertini.

    The fundamental ethical values are:

    1. Independence

    2. Loyalty

    3. Impartiapty

    4. Integrity

    5. Accountabipty

    6. Respect for human rights

    7. Obeying United States laws and regulations

    What Is the Average Salary Range for Regulatory Compliance Officer Positions?

    The average salary range for a varies, but the pay scale is rated "Standard" in Columbus. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.

    What Are the Key Qualifications for Regulatory Compliance Officer?

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    Interview Tips for Regulatory Compliance Officer Job Success

    The Ohio State University interview tips for Regulatory Compliance Officer

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    Before the Interview:

    Research: Learn about the The Ohio State University's mission, values, products, and the specific job requirements and get further information about

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