JOB SUMMARY

Performs archivist duties and various administrative activities to support the Quality Assurance (QA) Department at Novum in accordance with established policies and procedures. These activities include, but are not limited to, archival and retrieval of study or study related records, general administrative tasks, SOP/written procedure management activities, data entry, compiling QA metrics, and proofreading/quality control checks.

REQUIREMENTS

• Associate degree (A.A. or A.S.) or six months to one-year related experience; or equivalent combination of education and experience.
• Working knowledge of MS Word, MS Outlook, MS PowerPoint, and MS Excel software.
• Excellent communication and interpersonal skills.
  Maternity leave coverage
  1 year contract
  Job Type: Full-time
  Work Location: In perso

• Ensures that each concerned department has organized essential documents in Trial Master File in accordance with TMF checklist that allows accurate reporting, and archiving.
• Announces the archiving initiation for all the projects and tracks the archiving activities until the project is archived at off-site archiving facilities.
• Completes the electronic and hard copy archiving for all the projects and follows up with departments for archiving of the non-study specific archiving.
• Develop and ensures compliance of applicable policies or procedures for data archiving at Novum, Canada.
• Provides users with needed archival materials in accordance with Novum’s SOP/s.
• Prepares and maintains tracker for archived records to allow traceability and easy access to archived data.
• Creates and maintains accessible, retrievable computer archives and databases, incorporating current advances in electronic information storage technology.
• Preserves records, documents, and objects, copying records to film, videotape, audiotape, disk (CD/DVD), or computer formats, as necessary.
• Coordinate with contracted service provider to ensure data archiving and retrieval meets protocol/ Novum’s SOPs and applicable regulatory standards.
• Assists in maintaining a copy of a master schedule sheet of all non-clinical laboratory studies.
• Facilitates and manages Standard Operating Procedure (SOPs)/written procedure review cycles under the direction of QA Auditors.
• Assigns/allocates SOP/written procedure authors and reviewers in consultation with respective Head of Department (HOD)/QA designee, confirms SOP read lists with Head of Department(s), as appropriate.
• Communicates SOP author assignments and distribution of SOPs to HODs and QA auditors for internal review.
• Publishes SOPs and other training materials in the electronic learning management system (LMS), for title-specific and supplemental training.
• Sends training notifications to relevant staff.
• Maintains current and historical written procedures (e.g., SOPs, Master documents) files, trackers, master SOP and documents lists.
• Data entry of protocol/system deviations and quality events into their associated trackers.
• Compiles Quality Review Board (QRB) data and create QRB PowerPoint presentations for quarterly QRB meetings as well as scheduling QRB/QRM meetings.
• Create and distribute QRB meeting minutes.
• Other duties may be assigned.