Thermo Fisher Scientific Invites Job Applications

February 20, 2024

996

Job Description.

The Clinical Trial Coordinator (CTC) provides administrative and technical support to the Project Team. Supports audit readiness by ensuring that files are reviewed on the schedule specified in the organization’s SOPs and department guidance papers.
Conducts assigned file reviews for departments, internals, countries, and investigators, documenting findings in relevant systems.
Ensures projects are completed on time, within budget, and to high quality standards.
Actively conveys risks to project leaders.
Maintains study-specific documentation and systems, such as team lists, training needs, system access management, and project activity plans in the relevant system.
Offers system support.
Supports risk-based monitoring activities.
Handles administrative activities for assigned trials,

Timely processing of documents supplied to the client (electronic) Trial Master File (eTMF) as allocated, completing eTMF reviews, mass mailings, and communications as appropriate, and giving documents and reports to internal team members.
facilitates the scheduling of client and internal meetings.
Review and track local regulatory paperwork.
Sends documentation to clients and central IRB/IEC.
Analyse and reconcile study metrics and findings reports.
It helps clarify and resolve issues in site documentation.
Maintains vendor trackers.
Help coordinate, compile, and distribute the Investigator Site File (ISF), pharmacy binder materials, and non-clinical trial items to sites.
Supports study-specific translation materials and Quality Control (QC) upon request.

Providing administrative assistance for site-initiated changes and supply shipments.
Manage couriers.
Assisting CRAs with visit preparation.
Assisting Clinical Managers/Project Managers with country project-related expenses.
Assist with translation and quality control.
Distribute country- and site-level communications.
Create and manage an investigator list.
Quality control of country- and site-level papers
Submit comprehensive national and site-level papers to eTMF and track them in CTMS.
Tracks documents in CTMS, ensures country- or site-level activity plans are followed, and changes country-level activities and documents as needed.
Prepare and distribute ISF and Pharmacy binder to the site before the Site Initiation Visit (SIV).
Analyze eTMF data and dashboards to determine the status of critical documents at the country and site levels.
Follow up on missing or pending study documents to ensure they are supplied to the site.
Send “wet ink” papers collected from sites.
Update site-level activity plans and push study documents from country to site level.
Periodic safety reporting for urgent safety measures notification.

Closing Date: March 19, 2024