Overview

• Communication: Partake in meetings/teleconferences. Develop and distribute meeting agendas, minutes, monthly status reports, and action item distribution and tracking to document key project updates and communications to relevant stakeholders, as requested.
• Site Management: Assist with the development of sites budgets, contracts, and payments administration.
Support Clinical Trial Managers in tracking subject recruitment at all study sites, track study Monitoring Visits, protocol deviations, reporting and trending. Assist in communication to sites.
• Study Start-up: Support Clinical Trial Managers and Project Managers in the development of project plans and documents required for site feasibility, selection, and activation.
• Site Activation: Coordinate with the project team in retrieval and review of regulatory documents required for initiation of a clinical trial.
• Document Management: assist and help drive project team in the collection, review, filing, and archival of e read more... sential documents, and maintenance of the Trial Master File.
• Supplies Management: Assist with the coordination of logistics of the project, including printing of study tools and materials, securing study supplies, helping with the distribution, tracking and collection of study supplies and materials. Track clinical supplies at the site level in coordination with established study systems.
• Study Management: Assist project team members to create and maintain project trackers, relevant systems (e.g., CTMS, study portal) routine correspondence messages and distribute to project team, Sponsor, sites, and other stakeholders based on relevance.
• Vendor Management: Assist with the / [Performs vendor identification, qualification, selection, and management throughout a clinical trial, including administration of vendor payments.
• Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies. Assist the Project team in the resolution of audit findings; assist project team in review and maintenance of clinical trial documentation for audit readiness.
• Assist with financial reconciliation tasks
• Participate at client presentation meetings and Investigator Meetings (IM) as necessary.
• Communicate any out-of-scope issues to upper management as soon as identified.
• Assist the study teams in meeting timelines.
• May mentor junior Clinical Project Associates in particular tasks.
• Exhibit ability to perform CPA work with minimal support from CTMs and PMs on their assigned projects.

Languages

English Hindi Marathi

Education

Master of Science

Other skills

Project Scheduling, Research