Regulatory Compliance Specialist
New
F
Flourish ResearchClinical Research
United StatesFull-TimeJunior
Salary24 - 28 USD per hour
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Job Details
- Experience
- 2+ years
- Required Skills
- Microsoft OfficeHIPAA
Requirements
- Bachelor’s degree or equivalent experience.
- Minimum of 2+ years of experience within the field of clinical or biological research.
- Exceptional knowledge of clinical research methods.
- Proficiency with Microsoft Office (Outlook, Word, Excel) and internet-based applications.
- Detail-oriented with strong organizational and self-motivation skills.
- Excellent written and verbal communication skills.
- Ability to work independently and collaboratively in a team environment.
- Ability to adapt to changing tasks and prioritize competing demands.
- Ability to drive and daily availability of an automobile.
- Ability to lift up to twenty-five pounds.
- Industry certification is preferred as applicable.
Responsibilities
- Prepare, maintain, and provide oversight for all research-related regulatory documents.
- Coordinate the process of initial regulatory document submissions to IRBs, sponsors, and regulatory offices.
- Compile and submit study information, including initial, continuing, and final reports.
- Prepare and submit submission forms, amendments, addendums, safety information, and informed consent documents.
- Maintain accurate logs within regulatory binders and manage clinical trial document archiving.
- Prepare for monitoring visits and regulatory audits.
- Update and manage staff Curricula Vitae and medical/nursing license records.
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