Clinical Trial Coordinator

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Thermo Fisher Scientific to impact the world positively through meaningful work.

Division Specific Information

The global Clinical Research Group (CRG) team in the Functional Service Partnership (FSP) solutions area aids in all stages of clinical trials as needed by clients. Client-centered Clinical Trial Coordinators (FSP CTCs) partner with clients to offer operational and technical help, managing daily tasks for smooth trial operations.

As an FSP CTC, you'll work with the client as a partner, delivering a specific service. Duties involve offering admin and tech support, ensuring audit readiness, aiding in site activation, and managing service providers/vendors. Responsibilities may differ per client.

A Day in the Life:

• Collaborates with the study team throughout startup, maintenance, and closeout tasks, involving the gathering, assessment, and submission of documents to regulatory bodies.
• Guides electronic Trial Master Files (eTMF) throughout feasibility, study initiation, upkeep, and conclusion tasks (such as gathering and organizing documents, inputting study team rosters, incorporating/refreshing study site details, study progress, and other critical information)
• Performs eTMF quality and completion checks and initiates follow-up on resolutions when needed
• Assists with feasibility and site selection activities
• Manages access to the study system for the study team, site staff, and service providers/vendors
• Attends internal/external meetings and supports scheduling, agenda and meeting minutes creation/distribution
• Develops, sustains, assesses, and/or circulates study trackers, forms, newsletters, memos to study teams, sites, and service providers/vendors
• Support study lead in monitoring client's service provider(s) to ensure timely and accurate completion of assigned tasks (e.g., system integrity, product vendors, site management)
• Supports with administrative tasks related to inputting purchase orders, change orders, and generating financial reports, under the supervision of the study lead
• Could aid in coordinating trial/site insurance, tracking study supplies, and/or ensuring timely drug supply shipments
• Attends and/or assists in preparation for in-person meetings, such as Kick Off Meetings (KOMs), Investigator Meetings (IMs), or client Face to Face meetings
• May help with extra client administrative projects and tasks when necessary, like aiding in the onboarding process for new study team members

Keys to Success:

Education

• High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification. Bachelor’s degree preferred.

Experience

• Previous experience that provides the knowledge, skills and abilities to perform the job.
• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities

• Good organizational skills and strong attention to detail & prioritize/reprioritize multiple tasks efficiently and effectively
• Shown ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Proven skill in understanding and following relevant regulations, practices, and procedures for project management.
• Good English language and grammar skills and proficient local language skills as needed
• Good computer skills, including knowledge of Microsoft Office and/or Google Suite
• Ability to obtain knowledge and master all clinical trial database systems (e.g., Veeva, RAVE, SIP)
• Ability to quickly learn and adapt to client processes and systems (as applicable)
• Ability to work in a team or independently as required
• Self-motivated, positive attitude, and good communication skills
• Effective oral and written communication skills
• Essential judgment, independent thinking, and decision-making skills
• Capable of accurately following project work instructions

Physical Requirements/Working Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensive and reas