Regulatory Compliance Specialist I

New

United StatesFull-TimeEntry

Salary24 - 28 USD per hour

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Job Details

Experience: Minimum of 3 years’ experience within the field of clinical or biological research.
Required Skills: Microsoft ExcelHIPAA

Bachelor’s degree or equivalent experience.
Minimum of 3 years’ experience within the field of clinical or biological research.
Exceptional knowledge of clinical research methods.
Must be experienced with Microsoft Office applications (Outlook, Word, and Excel).
Experience with internet-based applications.
Detail oriented, organized, and self-motivated.
Ability to work independently and as part of a team.
Excellent interpersonal, written, and verbal communication skills.
Ability to adapt and take on additional tasks as requested.
Ability to solve problems while working closely across departments.
Demonstrated ability to collaborate and align with operations.
Industry certification as applicable.
Ability to lift up to twenty-five pounds and occasionally more.
Must have an automobile and be able to drive for local travel.

Prepare, maintain and provide oversight to all research-related regulatory documents.
Populate and coordinate the entire process of initial regulatory documents’ submission to the IRB, sponsors and state or federal regulatory offices.
Compile study information and submit initial, continuing and final reports to the IRB and/or sponsor.
Prepare and submit submission forms, amendments, addendums, investigator brochures, safety information, and informed consent documents.
Maintain all necessary logs within regulatory binders and manage the archival of clinical trial records.
Prepare for monitoring visits and audits.
Manage and update employee Curricula Vitae and ensure current licenses and certifications are on file.
Abide by all HIPAA regulations and maintain trade secret confidentiality.

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