Sr. Clinical Trial Coordinator

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Clinical Trial Coordinator

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.

Division Specific Information

As a PPD Clinical Trial Coordinator you will provide administrative and technical support to the Project Team from start-up to closure phase. You will support audit readiness by ensuring files are reviewed on schedule detailed in the organization's WPD and department guidance document. At PPD, we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

A Day in the Life:

Provides administrative and technical support to the Project Team. Supports audit readiness by ensuring files are reviewed on schedule detailed in the organization's WPD and department guidance document. Supports training of new staff and participates in departmental initiatives to support process improvements/enhancements.

Essential Functions:

• 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/clients, 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 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

Keys to Success:

Education and Experience:

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).

Knowledge, Skills and Abilities:

• Ability to work in a team or independently as required
• Solid organizational skills and strong attention to detail, with demonstrated ability to handle multiple tasks efficiently and effectively
• Strong customer focus
• Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
• Strong English language and grammar skills and proficient local language skills as needed
• Strong computer skills, proficient in MS Office (Word, Excel, and PowerP