Clinical Records Coordinator Job in Toronto, Ontario Canada

Reporting to the Manager of Clinical Operations, the Clinical Records Coordinator (CRC), is responsible for managing clinical documentation maintained within the Records Centre and coordinating off-site archiving activities.  This role also serves as  a support function for the Clinical Research Department, assisting with processing/QCing clinical documents and tracking document receipt.  The CRC is accountable for ensuring accurate filing and tracking of clinical records housed in the Records Centre and at the off-site archival facility.

Key Responsibilities:

A) DOCUMENT MAINTENANCE (75%)                                                                                                

Receive, QC, and File essential clinical documents in the appropriate Country and Site-Level Trial Master File as per the Records Centre process and procedures. Track receipt of Clinical documents in tracking databases and/or tracking spreadsheets
Monitor Records Centre email account for Records Centre requests (e.g. retrieval and archiving) and action requests in a timely manner
Conduct Trial Master File binder audits and follow-up on outstanding items as necessary
Communicate missing records to the appropriate individual, as necessary
Provide documents to Lilly personnel within agreed upon timelines
Other tasks, as assigned

B) DOCUMENT ARCHIVAL MAINTENANCE  (10%)

Submit inactive studies and/or documents for archival upon request
Action requests for retrieval of archived documents in a timely manner
Maintain accurate tracking of all archived and retrieved documents

C) INVESTIGATOR DOCUMENT ARCHIVAL (10%)

Assist Investigators with the archival of documents once formal requests are received from Lilly Clinical Research Department personnel
Execute requests per the Records Centre process

D) RECORDS CENTRE MANAGEMENT AND PROCESS IMPROVEMENT (5%)

-Manage the organization and filing system logistics of the Records Centre and ensure system facilitates quick identification and access to files/binders
-Develop and deliver training on Records Centre process to Clinical Research Department personnel, as needed
- Provide feedback to the Process Owner and/or Training and Quality Functions when Records Centre process training gaps are identified or to communicate suggested process improvements
- Update/maintain the Records Centre Disaster Recovery Plan (DRP)
- Oversee the execution of the Records Centre DRP as necessary (this may involve work outside of regular business hours)

3) RESPONSIBILITY

-Checks accuracy of documents that document owners have submitted for filing
-Provides technical or functional guidance to Records Centre back-up personnel

4) SKILLS (Education and training)

Associates or Bachelor degree
Experience in developing and maintaining a system of records (preferably in a regulated environment)
Good knowledge of MS Office, Excel (able to write and run macros)
Previous clinical trial experience an asset
Four months experience
Meticulous Attention to detail
Critical thinking
Ability to work independently
Good communication skills
Excellent organizational skills
Ability to manage work in order to meet strict timelines
Must be able to communicate verbally and tactfully with both internal and external contacts

Please send resume to Kimberly Littlefield at k.littlefield@brunel.net