Archivist

Job Description

Summarized Purpose: Operates an archive and document control systems. Logs, stores, retrieves, and monitors circulation of records which may include analytical methods and protocols and project and general laboratory raw data or Investigator site files. Ensures compliance with applicable facility SOP's and FDA Good Pharmaceutical Practices (i.e. Good Laboratory Practices, Good Manufacturing Practices etc) including maintaining security of the archives.

Essential Functions• Places data and other records in the facility archives and catalogs these items appropriately to facilitate prompt retrieval. Maintains appropriate tracking records in the archive database.• Prepares project and equipment notebooks in accordance with laboratory specifications. Assigns and distributes notebooks to laboratory staff.• Catalogues and maintains analytical method and protocol files. Provides controlled copies of analytical methods to laboratory staff, and maintains distribution records in the archive database.• Conducts reviews of study files prior to submission to permanent storage.• Interacts with commercial (offsite) archive facilities for data storage and retrieval.• Troubleshoots and resolves missing or incomplete documentation of the study boxes.• May provide training on departmental tasks as appropriate.

Job Complexity: Works on assignments that are semi-routine in nature but recognizes the need for occasional deviation from accepted practice.

Job Knowledge: Applies acquired job skills and company policies and procedures to complete assigned tasks.

Supervision Received: Normally follows established procedures on routine work, requires instructions only on new assignments.

Business Relationships: Contacts are typically with individuals within own department and occasionally with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation.

Qualifications

Education and Experience: High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification. Technical positions may require a certificate. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities• Knowledge of Federal Regulations, ICH GCPs and procedural documents• Strong computer skills, including MS Office programs• Strong organizational and time management skills• Excellent verbal and written communication skills• Ability to multi-task and handle multiple priorities• Ability to work in a collaborative team environment

Management Role: No management responsibility

Working Conditions and Environment: Work is performed in an office or clinical environment with exposure to electrical office equipment. Occasional drives to site locations. Potential Occasional travel required.

Physical Requirements:• Frequently stationary for 4-6 hours per day.• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.• Occasional mobility required.• Occasional crouching, stooping, bending and twisting of upper body and neck.• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.• May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.• Works with guidance or reliance on oral or written instructions from management. May require periods of intense concentration.• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.• Regular and consistent attendance.