Regulatory Affairs Coordinator - United States
- Our company is a leader in Early Stage Clinical Research, has an excellent opportunity for a Regulatory Affairs Coordinator at our fast-paced facility.
- Every member of our company is involved in making a distinctive contribution to the health and well-being of people around the world.
- That's the sense of purpose shared by our employees. We are a performance-driven drug research company, operating in robust and growing markets.
- We have an exciting future and offer a strong development environment for our great employees.
- Organize and maintain all Study Binders including set up, archival and creation of templates.
- Organize and maintain the Investigator Site File including set up, archival and creation
- Maintain and ensure completion of financial disclosure forms including obtaining signatures and submitting the forms.
- Maintain and ensure completion of essential study documents in compliance with Good Clinical Practice.
- May maintain all current and historical copies of laboratory accreditations, reference ranges, staff Curriculum Vitae (CVs), medical licensures, and related forms. Request updates when necessary.
- Responsible for assisting in on-site and off-site storage including vendor budget as well as obtaining records for audits or as needed.
- Ensure all protocol and protocol amendments are signed accordingly
- Responsible for all study and non-study specific IRB approvals
- Responsible for assisting study management with responding to queries with regard to regulatory binders during study monitoring visits.
- Coordinate and oversee activities of On-site and off-site study archives.
- Shall archive and/or work closely with all other departments to archive, off-site, all studies approximately six months after study is closed out by the IRB.
- 2 years after study is closed out by the IRB
- Responsible for scanning, uploading and filing all study documents to Celexus.
- Associate's degree in life sciences or equivalent preferred
- Two or more years of regulatory experience
- Strongly prefer experience with IRB/FDA and/or other regulatory bodies and guidelines
- Must have strong organizational, attention to detail, multi-tasking, and time management skills
- Excellent oral and written communication skills
- Hours will be during normal business hours. M-F
- Overtime may be required