Clinical Trial Coordinator

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