- BSc in the sciences; Clinical Research Certification an asset
- Experience in administrative, filing of regulatory documents
- Ability to manage clinical study specific materials and liaise with CRAs and other clnical staff
Clinical Trials AssistantToronto, ON, Canada
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CLINICAL TRIALS ASSISTANT
Manage and maintained study documentation for clinical studies.
Participate in daily clinical study activities.
Manage and maintain a controlled records management system for trial master file and related clinical trial documents.
Liaison with clinical trial sites, CRO and internal study team to facilitate the collection, filing and tracking of regulatory documents and other related study documents, including monitoring reports.
Conduct routine quality and completeness reviews of study files, trackers and ensure all documents are up to date. Facilitate the collection of updated records where applicable and ensure any issues identified are resolved in a timely manner.
In co-operation with Quality Assurance, participate in record managements system review. Ensure the proper filing, maintenance, and archiving of approved study documentation within the CRO, study sites, and company.
Monitor and manage the clinical study mailbox on a daily basis.
Prepare regulatory packages and study start-up binders and tools for clinical trial sites.
Coordinate shipment of trial materials to clinical trial sites as necessary.
Coordinate site training with study trainers and clinical site study coordinators when required.
Collect and compile the set of study documents required for the release of investigation product to trial sites, for review by the Project Manager and Quality Assurance.
Communicate with CRO as required for the management of day-today trial activities.
Provide project support as needed to the VP of Clinical Development and the Project Manager on specific tasks, as assigned.
Bachelors of Science (BSc.) or Equivalent
Clinical trial management Or Equivalent
Basic knowledge of the clinical trial process. Knowledge of ICH guidelines and GCP including basic understanding of regulatory requirements is an asset.
Understanding of the regulatory progression of establishing and maintaining clinical sites
Ability to clearly and effectively communicate within the team, CRO, clinical sites and vendors
Excellent organizational skills, detail oriented and the ability to manage multiple projects
Excellent oral and written skills; ability to work independently and adjust to a rapidly changing environment
Advanced Microsoft Office Word, Excel and PowerPoint programmes knowledge and understanding
>1 year experience in pharma and/or, biotech clinical research is an asset
1-2 years experience and knowledge in document management
Demonstrated success at completing projects accurately and on time
Category: Biotechnology & Pharmaceutical
Reference ID: CA7677BM001341
Date Posted: 13/03/2019