
Clinical Trials Coordinator
6 days ago
Job Title: Senior Assistant Project Manager
About the RoleThis is a key position within our organization, responsible for managing multi-site investigator-initiated trials from start-up to close-out.
Key Responsibilities:Project manage multi-site clinical trials (investigator-initiated)
Monitor trial progress and ensure trial operates within budget and timeline
Do budget forecasts
May assist PI in obtaining funding from industry partners and/or grants, including contracting and grant application/extension
Manage timely funding and payment throughout trial duration
Liaise with vendors throughout trial duration (for outsourced activities such as site monitoring, biological samples testing, data management), including contracting, setting up processes, developing/reviewing manuals and issue resolution
Liaise with drug company/vendors to manage clinical supplies (investigational product, lab kits) throughout trial duration
Review and maintain trial master file
Work closely with sites as the main point of contact for operational activities including but not limited to contract execution, site payments, biological samples and data collection, safety reviews, clinical supplies, issue resolution, data cleaning and publication
Anticipate risks and take action to mitigate/avoid them, where applicable.
Perform quality checks on site clinical trial documentation
Review ISF and participant binders for adherence to ALCOA principles, trial protocol and regulatory requirements
Assist NCCS site in audits and inspections by working with site team on preparatory work and CAPA plans
Assist with various tasks for the department as assigned
May include but not limited to: Developing/reviewing department P&Ps and Work Instructions, and tracking staff training.
Degree in life science, biomedical sciences or any related study.
At least 4 years of clinical trial experience, including minimum 1 year of clinical trial management experience.
CRA experience is required.
Meticulous with close attention to timelines
Able to handle multiple priorities independently
Strong organizational skills
Strong communication and interpersonal skills
Committed team player
Able to assess situations independently and recommend solutions
Fluent in both written and spoken English
Proficient in Microsoft Excel, Word and PowerPoint
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