This job is currently Archived,
Posted on : 21 June 2017
Celerion, a leader in Early Stage Clinical Research, has an excellent opportunity for a Regulatory Affairs Coordinator at our fast-paced facility. Every member of Celerion 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. We are hiring a part-time (benefits included) Regulatory Affairs Coordinator in our Phoenix location. Responsibilities: 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 (Phoenix). Responsible for scanning, uploading and filing all study documents to Celexus. Qualifications: 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 Additional Information: Hours will be during normal business hours. M-F Overtime may be required EEO/AA M/F/Vet/Disability Internal applicants are encouraged to apply.
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