FSP Clinical Trial Coordinator II

Thermo Fisher Scientific

Full-time

Remote

Computer and Electronic Product Manufacturing

About the position

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies. As a Clinical Trial Coordinator II, you will provide administrative and technical support to the Project Team. You will support audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. You will also provide administrative support for site activation activities and aid in the development of the critical path for site activation within assigned projects in support of rapid site activations. Your role may involve using 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. Additionally, you may act as a buddy during the onboarding phase and provide training to new staff as needed.

Responsibilities

• Provides administrative and technical support to the Project Team.
• Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document.
• Provides administrative support for site activation activities.
• Aids the development of the critical path for site activation within assigned projects in support of rapid site activations.
• Represents CRG personnel.
• Develops and reviews site lists suitable for the strategic needs of feasibility activities.
• Acts as a buddy during onboarding phase and provides training to new staff as needed.
• 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 timely processing of documents sent to Client (e)TMF as assigned.
• Reviews and tracks local regulatory documents.
• Analyzes and reconciles study metrics and findings reports.
• Maintains vendor trackers.
• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials.
• Assists with study-specific translation materials and translation QC upon request.
• 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.
• Develops and maintains relationship with client local affiliates.
• Champions the inclusion of Strategic Collaboration sites into the process.
• Conducts on-site feasibility visits (Asia Pac only) where applicable.
• Trains new personnel in processes and systems.
• Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers.
• 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 transmit documents to client and centralized IRB/IEC.
• May attend Kick off Meeting and take notes when required.
• May support scheduling of client and/or internal meetings.
• Provides support as needed to coordinate with internal departments and ensure site start-up activities within the site activation critical path are aligned.

Requirements

• 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).
• Experience in SSU/Regulatory Process.