Summary: Oversight of the Trial Master File for assigned study(ies), assistance to the study project managers/leads, regulatory and management, as required.
- Timely maintenance of the Trial Master File (TMF) to ensure audit readiness in compliance with regulatory requirements for document control and correspondence record keeping.
- Tracking, saving, printing and filing all essential documents from study sites.
- Auditing each site’s Essential Documents at regular intervals to assist in the management of clinical trials. This can involve contacting the sites, project leads or monitors to track down missing documents.
- Preparation of Study Start up Binders and Folders for upcoming sites.
- Preparation of study supplies as requested from sites and packaging for courier.
- Track patients from enrollment through all cycles of treatment and follow up. This tracking is important to clinical, management and accounting.
- Regularly audit and track all trip reports to ensure that all visits recorded on the monitoring calendar have a corresponding report in the TMF.
- Assist with managing the tracked documents in preparation for IB updates, protocols (new and amended), study reports and any other major documents, as required.
- Collation and assistance with regulatory submission packages for FDA or Health Canada.
- Audits all files for archiving to ensure complete data set, once study has been locked and study report completed.
- Attend and provide invitations to meetings for various project teams and produce minutes and updated action item trackers for same.
- Assistance with preparation for due diligence and audits as required.
- Excellent oral, written and interpersonal skills
- Excellent organization skills: filing knowledge
- Attention to detail
- Proficiency in software applications such as MS Project, Word, Excel, and PowerPoint
- Experience in and understanding of ICH GCPs preferred
- Undergraduate degree in a clinical or health related field preferred, or relevant experience.
- A minimum of one year of previous professional experience in a related field preferred.
- Management of file systems (both electronic and paper)