Archivist - Lincoln, NE

Archivist - Lincoln, NE

Celerion is committed to swift, exceptional clinical research through translational medicine.  Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.  

Celerion is looking to hire a Full-time Archivist that will work onsite at our Lincoln, Nebraska location. This job will involve coordination of archiving and document management for different lines of business.  Coordinates and prioritizes projects in all areas of archives.

·       For new study numbers, creates inventory tracking page and does inventory data entry

·       Prints and files email correspondence from archives email account

·       Approves personnel additions to restricted archive facilities access list & any revisions.

·       Responsible for oversight of environmental monitoring & any alarm notifications & responses.

·       Coordinates preparation for Clients (Requests/Visits/Audits), Regulatory Authority Inspections (FDA, EMA, etc.); including retrieving documents for internal clients, external clients, and Regulatory Authority Inspections; gives tours and procedural overviews to clients during audits, monitoring, and site qualification visits/audits

·       Maintains accounts and communication with long-term off-site storage facility (Iron Mountain).  Authorized administrator for all Celerion North American sites accounts for long-term storage facility.

·       Responsible for inventory maintenance & retrieval of study data materials for decommissioned sites stored in their original long-term storage facility; responsible for providing information & study data materials resulting from client requests pertaining to inventories of decommission sites.

·       Appointed Archivist for archiving and de-archiving electronic data for multiple Celerion teams/departments.

·       Responsible for: Coordination of submission of inventory from different departments to archives; Checking in new inventory of any raw data (clinical and analytical); Maintenance of check-in and -out log and email reminders for checked out materials; Training authorized associates on process to check out materials from archives; Retrieval of documents from authorized associates separating from company; Preparation of boxes sent to off-site storage facility and maintenance of data transfer records of inventory at off-site storage facility

·       Maintenance of decommissioned site studies that are stored at the Lincoln site long-term facility

·       Oversight and maintenance of the following inventories: historical company records, SOPs, training files, HR files, agreements and contracts, radiation licensure files, e-archiving submission and retrieval documentation, any and all permanent records submitted for archiving.

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Requirements:

• Bachelor’s degree in a related discipline is highly preferred; equivalent experience in lieu of degree will be considered
• 1+ years document management experience; preferably regulatory-related to clinical trials
• Ability to independently manage tasks and priorities
• Excellent organizational and problem-solving skills required, and the ability to track projects
• Excellent verbal and written communication skills
• Proficient computer skills, i.e., PDF, MS Word, Excel, Smartsheet, Tera-Copy.
• Ability to lift up to 50 lbs.

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Celerion Values:       Integrity   Trust   Teamwork   Respect

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.