FSP Clinical Trial Coordinator

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Description

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.

Discover Impactful Work:

The Clinical Trial Coordinator provides administrative and technical support to the Project Team. Candidates must hold 1-2 years of clinical trials-related experience and be familiar with Veeva Vault (CDMS and CTMS) with proven ability to manage meeting agendas and minutes. They must also demonstrate proficiency in maintaining study team rosters, understanding the importance of TMF quality control for inspection readiness, and effectively monitoring site reports while addressing concerns with the CSM. Additionally, experience in maintaining an organized list of Standard Operating Procedures (SOPs) is essential.

Those candidates with vendor budget/invoice tracking experience and familiarity with systems to check enrollment, timelines, and run metric reports among other duties are a significant plus.

Education

Bachelor's degree preferred. In some cases, additional vocational qualifications may be considered in lieu of a degree.

Experience

Previous experience that provides the knowledge, skills, and abilities to perform the job (at least 1year). Strong experience in CTMS systems and eTMF systems (specifically Veeva Vault).

A day in the Life:

• Coordinates, oversees and completes functions on assigned trial(s) activities.
• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings. 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. Maintains vendor trackers.
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
• 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.
• Trains new personnel in processes and systems.
• Ensures (e)TMF is up to date by following file review schedules and documenting findings in appropriate system(s).
• May support scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
• May assist with start-up activities and support start-up team in Regulatory submissions.
• Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
• May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites. Harnesses this knowledge base when performing local tiering of sites.

Knowledge, Skills, Abilities

• Strong organizational skills and attention to detail, with proven track record to handle multiple tasks efficiently and effectively
• Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Strong customer focus
• Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
• Good presentation skills
• Excellent digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
• Self-motivated, positive attitude with effective strong interpersonal skills