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Regulatory Assistant

IACT Health

Regulatory Assistant

Columbus, GA
Full Time
Paid
  • Responsibilities

    Regulatory Assistant

    Reports to: Regulatory Manager

    Grade: 4

    Directly Supervises: This position does not have direct reports

    Expectation for all employees: To support the organization’s passionate cause, vision, and FUNdamentals by exhibiting the following behaviors: excellence and competence, collaboration, innovation, respect, accountability, and ownership.

    Position Purpose: Facilitates professional service in clinical trials industry by processing regulatory documents efficiently; ensures compliance with all FDA regulations in research documentation; communicates professionally with IRBs, CROs, and Sponsors; maintains trial tracking documents and software.

    Essential Responsibilities:

    Ensure accuracy, completeness and consistency of data for submission to Sponsor, CRO and IRB in multiple clinical trials

    Gather, enter and/or update data to maintain company records and databases; establish and maintain electronic files and records for sites

    Submit regulatory documents and other documents, as necessary, on behalf of the Affiliate sites

    Obtain appropriate documentation to support submission of Affiliate Site to Sponsor, CRO and IRB including Principal Investigator’s signed and dated CV, copies of medical license and practice demographics

    Assist in maintaining current regulatory documents during the entire clinical trial process

    File new or revised documents electronically

    Communicate all regulatory needs (update CVs, request IATA and GCP certificates, verify licenses and local lab documentation) in a timely manner

    Prepare documents for regulatory binders and send documents to Affiliate Sites for filing, as applicable

    Assist Clinical Research Coordinators by providing documentation to Sponsors/CROs upon request

    Create and maintain spreadsheets as needed

    Other duties and responsibilities as assigned

    Minimum Position Requirements:

    Education: Appropriate education and/or experience may be substituted on equivalent basis

    Required: HS/GED

    Preferred: Bachelor’s Degree in related field

    Experience:

    Preferred: 1 year or more of professional experience

    Knowledge, Skills, & Abilities:

    Ability to maintain professionalism and professional standards. Must have a sense of urgency. Set priorities. Identify and resolve problems effectively and efficiently. Excellent communication and organizational skills for managing workflow and follow-up. Ability to demonstrate reliability and maintain confidentiality. Must have a “do-what-it-takes” attitude. Excellent speaking skills to communicate clearly and effectively with patients, physicians, industry professionals, and others in person or over the phone.

    Background Checks:

    Background and criminal history check

    Drug Screen

    Others as needed

    Physical Demands:

    Manual Dexterity: Work requires moderate speed and accuracy, excellent keyboarding skill

    for computer use.

    Physical Effort: Work requires considerable variety of fairly steady active physical exertion.

    Some and/or continuous standing or walking. Some lifting of items less than 20

    lbs.

    Working Conditions: Potential for early morning and/or late-night responsibility

    Travel: Travel is not a regular expectation of this position