FSP_Clinical Trial Coordinator (Sponsor: Roche)

Thermo Fisher ScientificRemote, Korea, Republic ofremoteSalary not postedView the original posting at Thermo Fisher Scientific ↗

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description FSP_Clinical Trial Coordinator (Sponsor: Roche) As part of our global team, you’ll have the opportunity to provide administrative and technical support to the Project Team. As a Clinical Operations Delivery Associate II, you'll support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. You will provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects to support rapid site activations. Representing the organization in the global medical research community, you may develop collaborative relationships with investigators and site personnel to conduct feasibility assessments in accordance with feasibility processes and within deliverable timelines. You may develop a local knowledge base of sites in the respective market through collaboratively working with local company personnel. Additionally, you may utilize local knowledge, organization systems, external site lists, and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process. You may act as a buddy during the onboarding phase, support training of new staff, and participate in departmental initiatives to aid in process improvements and enhancements. What You’ll Do: • According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix. • Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system(s). • 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. • 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, distributing mass mailings and communications as needed, providing documents and reports to internal team members. • Reviews and tracks local regulatory documents. • 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. • Assists with technical and administrative support for projects in collaboration with internal departments and team members. • Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided. • Ensures that trial status information relating to activities is accurately maintained in the database and current at all times. • Where applicable, develops and maintains relationship with client local affiliates. • Champions the inclusion of Strategic Collaboration sites into the process. • Where applicable, conducts on-site feasibility visits (Asia Pac only). • Trains new personnel in processes and systems. • May support 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/clients and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s). • May provide system support (i.e., Activate & eTMF). • May support RBM activities. • May tra

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