Regulatory Document Specialist
|Title:||Regulatory Document Specialist|
|Department:||Early Clinical Research|
|Job Status:||Full Time|
Celerion, a leading international research organization headquartered in Lincoln, NE is seeking a Regulatory Document Specialist to join our team. This individual will act as a liaison among Study Managers, Internal Review Board (IRB) Representatives, Admissions, Principal Investigators, and Project Management regarding study specific regulatory documents.
- Organize and maintain all the Investigator Site File (ISF) including set up, archival and creation of templates.
- Track IRB letters and ensure that the documents referenced are placed in the ISF
- Perform Quality Control (QC) on all regulatory binders before the Quality Assurance (QA) audit of critical documents is completed
- Respond to any QA findings in critical documents audit to ensure proper documents are placed in the regulatory binder
- Create 1572 packets for all studies and ensure completeness prior to sponsor delivery and subsequent filing
- Maintain master signature logs and ensure they are updated
- Maintain all original study correspondence and distribute accordingly including client correspondence
- Maintain Delegation of Authority log real-time.
- 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.
- May attend study close-out visits including preparing close-out documents and ensuring the study is complete according to the client, FDA, and all requirements.
- May be involved to ensure all protocol and protocol amendments are signed accordingly
- Responsible for all study and non-study specific approvals and study expiry tracking
- May respond to queries with regard to regulatory binders during study monitoring visits.
- May be responsible for submitting any and all pertinent documents to the IRB or Sponsor for acknowledgement or approval.
- May oversee maintenance of database of completed studies and manage physical disposition of study records
- Research archived data as requested
- Special projects as needed.
- May review study related mail directed to investigators to ensure quality for all studies
- Coordinate and oversee activities of Central Files (on-site, limited access study storage area).
- Shall archive and/or work closely with all other departments to archive data as needed
- Shall track and keep a running log of all visitors in and out of the file room
- Shall track and keep a running log of all study documents that are received and taken from the Regulatory Affairs Coordinator.
- Shall maintain and update all study related documents that enter and exit the file room.
- Assist coordination of submission of all study data from different departments to Central Files
- Additional duties as determined by the manager to meet departmental goals.
- Responsible to upload all ISF documents to Celexus on an ongoing (real-time) basis
- 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