Clinical Trial Coord
hace 3 semanas
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
- Ensures allocated tasks are performed on time, within budget and to a high-quality standard.
- Proactively communicates any risks to project leads.
- Supports the maintenance of study specific documentation and systems including but not limited to: study team lists, tracking of project specific training requirements, system access management, and tracking of project level activity plans in appropriate system.
- Provides system support (i.e. GoBalto & eTMF).
- Supports RBM activities.
- Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
- Supports scheduling of client and/or internal meetings.
- Reviews and tracks local regulatory documents.
- Transmits documents to client and centralized IRB/IEC.
- Analyzes and reconciles study metrics and findings reports.
- Assists with clarification and resolution of findings related to site documentation.
- Maintains vendor trackers.
- Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
- Assists with study-specific translation materials and translation QC upon request.
Other responsibilities may include, but are not limited to:
- Providing administrative support for site-initiated amendments and site supply shipments.
- Manage couriers.
- Supporting CRAs in visit preparation.
- Supporting CTMs/PMs in country project related expenditures.
- Assist in translation and translation QC.
- Distribute country and site level communications.
- Create and maintain investigator list.
- QC of country and site-level documents.
- Submission of complete country and site-level documents to eTMF and related tracking in CTMS.
- Performs document tracking in CTMS, verifies appropriate country or site level activity plans are applied, updates country level activities/documents for amendments.
- Compile and distribute Investigator Site File (ISF) and Pharmacy binder to site prior to SIV.
- Review eTMF reports and Preclarus dashboards to identify country and site level essential documents statuses.
- Follow up on outstanding/missing study documents to be sent to site.
- Forward "wet ink" documents retrieved from sites.
- Apply updated site level activity plans, including push down of study documents from country to site level.
- Periodic Safety Reporting for Urgent Safety Measures Notifications.
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