According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.

• 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

Qualifications:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
Bachelor's degree preferred.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role