WFH Clinical Trial Coordinator Position at Thermo Fisher Scientific! Apply Now!
Sr Clinical Trial Coordinator
Location: Remote, India
Job Id: R-01296575
Job Type: Full time
Category: Clinical Research
Remote: Fully Remote
Work Schedule: Second Shift (Afternoons)
Environmental Conditions: Office
Job Description: Sr Clinical Trial Coordinator (Sr CTC)
Minimum Education and Experience: Bachelor’s degree or equivalent experience with minimum three years of relevant experience.
Roles/Responsibilities:
- Analyzes and reconciles study metrics and findings reports.
- Assists with clarification and resolution of findings related to documentation according to the specific role (central or local), coordinates, oversees, and completes functions on assigned trial activities.
- Completes file reviews/completeness checks based on client requirements to ensure TMF inspection readiness.
- Uses critical thinking to ensure tasks are proactively scheduled and fulfilled in line with project team needs.
- Proactively communicates any risks to project leads and line manager as appropriate.
- Supports the maintenance of study-specific documentation and global support with specific systems, tools, and trackers, including, but not limited to, study team lists, tracking of project-specific training requirements, system access management for organization/vendor/clients, and tracking of project-level activity plans in appropriate system(s).
- Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system(s).
- Reviews and tracks local regulatory documents. Supports the project team to ensure audit readiness, (e.g., [e]TMF) and contributes to internal, regulatory, and client audit responses as needed.
- Provides system support (e.g., Activate and eTMF) and ensures systems databases are always current.
- Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
- Ensures that trial status information relating to activities is accurately maintained in the database and is always current.
- Trains new personnel on processes and systems.
- Contributes to discussions with teammates in other regions to support a collaborative network with consistent processes and sharing of best practices.
- Provides training to other functional team members.
- Serves as an alliance-level lead, handling client (e)TMF activities.
- Provides technical and administrative support and coordination for projects in collaboration with relevant internal departments and team members.
- Aggregates and analyzes TMF-related data in BIs TMF System & related tools.
Link to apply: APPLY ONLINE HERE
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