Regulatory Coordinator
3 weeks ago
Qualifications
Minimum Qualifications
Associate degree in Clinical Research or related OR 3 years direct clinical research-related experience within the last 5 years
Must have:
- Problem solving, analytical, resource management, and creative thinking skills
- Ability to plan and schedule tasks and projects and complete them in a timely manner
- Ability to delegate duties while maintaining responsibility for completion of tasks
Licensure, Registration, Certification
Certified Clinical Research Professional (CCRP) through the Society of Clinical Research Associates (SOCRA) certification
If not currently certified in CCRC, certification must be obtained within 12 months of qualification for exam
Desired Qualifications
Bachelor's degree
Understanding of:
- Good Clinical Practice (GCPs) and all regulatory requirements of the FDA
- Microsoft Office Suite, research specific software, and other general office equipment
Licensure, Registration, Certification
Regulatory Affairs Certification (RAC) through Regulatory Affairs Professionals Society (RAPS)/ Certified IRB Professional (CIP) certification
Responsibilities
The Coordinator Regulatory (RC) is responsible for coordinating activities related to the submission and maintenance of regulatory files, preparation of informed consent forms, study summaries, and IRB submissions. Works closely with research staff on various screening and data reports. Ensures compliance with Institutional, IRB, FDA, and sponsor guidelines/regulations and standard operating procedure requirements. The CR is also responsible for demonstrating professional demeanor and maintaining confidentiality in all interactions with both internal and external contacts.
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