Work Schedule

Environmental Conditions

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