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| Position Type: | Full-time |
| Location: | London, ON |
| Date Posted: | Jul 26, 2021 |
Job Description
POSITION LOCATION: London, ON
POSITION TITLE: TMF Coordinator (Full-time, Permanent)
POSITION REPORTS TO: Team Lead, TMF Operations
DEPARTMENT/UNIT NAME: TMF Operations
JOB SUMMARY:
Support Trial Master File (TMF) activities to ensure TMFs are “inspection ready” throughout study life cycle and TMF documents are filed contemporaneously. Primarily responsible for document attribute review, processing, tracking and filing; and paper and/or electronic folder creation. Serve as the main contact for the secure file room. Work proactively and successfully within a cross-functional team. Embody department and company goals and practices. Interact with stakeholders in a way that fosters a positive working atmosphere and encompasses a professional and helpful attitude. Time allocated may be adjusted based on need.
AREAS OF RESPONSIBILITY:
Service Delivery
o Receive, log and track study documentation in TMF system(s) while identifying defective documents.
o Process and review documents, following applicable scanning and coding procedures and best practices, and applying ALCOA principles appropriately.
o File and retrieve TMF documents in a timely manner.
o Prepare paper and electronic folders in accordance with established TMF folder structures.
o Understand priorities and timelines to plan day-to-day workload.
o Draw on knowledge to address inquiries, escalating as needed.
o Assist with activities in preparing TMF for audits, file reviews and transfers.
o Perform other study TMF-related tasks as required by the study teams and/or senior leadership.
Department Support
o Complete routine administrative tasks in a timely manner.
o Maintain department specific office supplies.
o Preform activities related to the secure file room.
o Assist with the planning and execution of in-house archiving and in the organization and filing of clinical and corporate records.
o Share ideas for the improvement of processes and systems to help with the efficient operations of the department.
QUALIFICATIONS:
Applicants should have a minimum of a one or two-year post-secondary diploma/certificate + training/less than 1 year of relevant experience OR high school diploma + 1-3 years of experience/training. Further, the successful candidate will possess advanced knowledge of MS Office.
WORKING CONDITIONS:
Office Based (temporarily home-based due to the pandemic)
*Accommodations for job applicants with disabilities are available
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