Clinical Research Regulatory Specialist
New
J
JobgetherClinical research
Based in the United StatesFull-TimeJunior
Salary not disclosed
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Job Details
- Languages
- Fluency in spoken and written English
- Experience
- 1–2 years of clinical research experience
- Required Skills
- Microsoft ExcelHIPAA
Requirements
- High school diploma or equivalent required; a bachelor's degree is preferred.
- 1–2 years of clinical research experience, preferably in regulatory affairs, regulatory documentation, or quality assurance.
- Current Good Clinical Practice (GCP) certification.
- Relevant professional licenses or certifications, including continuing education units (CEUs), where applicable.
- Sound understanding of medical terminology and clinical research processes.
- Working knowledge of ICH/GCP guidelines, applicable regulatory requirements, FDA regulations, and HIPAA policies and practices.
- Familiarity with clinical research regulatory documentation, IRB submissions, Investigator Site Files, and study startup and maintenance procedures.
- Proficiency in Microsoft Office, particularly Microsoft Excel, as well as Adobe Acrobat and related document management tools.
- Fluency in spoken and written English.
- Ability to manage multiple priorities and changing deadlines, gather documentation from multiple sources, and prepare accurate regulatory materials.
Responsibilities
- Coordinate study startup activities, including IRB submissions, regulatory documentation, vendor access, and staff training access.
- Administer the Florence eRegulatory platform by creating electronic study binders, filing documents, and conducting quality checks.
- Prepare, review, and maintain essential regulatory documents, including FDFs, PSPs, FDA Form 1572s, and Investigator Brochure Signature Pages.
- Distribute documents for review and signatures, monitor outstanding requirements, and coordinate follow-ups.
- Submit completed regulatory documentation and investigator credentials to sponsors and CROs within established deadlines.
- Create and maintain delegation of authority logs and training logs.
- Review Investigator Site Files for completeness, accuracy, consistency, and regulatory compliance.
- Prepare documentation for Site Selection Visits, including CVs, medical licenses, GCP training certificates, SOPs, and equipment calibration records.
- Prepare investigator CVs, coordinate updates, and obtain and maintain valid medical licenses.
- Prepare and submit continuing reviews, protocol deviations, and other ongoing IRB documentation.
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