Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed on schedule detailed in in the organization’s WPD and department guidance document. Supports training of new staff and participates in departmental initiatives to support process improvements/enhancements.
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 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/clienst, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings 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 and organization of client and/or internal meetings with completion of related meeting minutes.
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.
May attend Kick off meeting and take notes when required.
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 at least 2 years).
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.