Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description

Purpose:

Thermo Fisher Scientific Inc. is seeking a Clinical Trial Coordinator (CTC) to join our team. You will have the opportunity to work on world-class research projects and collaborate with experts in a fast-paced environment to ensure flawless execution and efficient site activations.

Essential Functions:

• Coordinate, oversee, and successfully implement functions on assigned trials.
• Perform meticulous department, internal, country, and investigator file reviews, documenting findings.
• Ensure tasks are completed on time, within budget, and to a high-quality standard; proactively communicate risks.
• Provide system support and maintain current, accurate databases.
• Complete various administrative tasks, such as processing documents in a timely manner, conducting e TMF reviews, and distributing communications.
• Analyze and reconcile study metrics, aiding in resolution of site documentation findings.
• Coordinate and distribute Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies.
• Assist in study-specific translation materials and quality control.
• Maintain knowledge of SOPs, client directives, and regulatory guidelines.
• Conduct on-site feasibility visits as required.
• Support scheduling of client/internal meetings and track regulatory documents.
• Provide system support, including Activate & e TMF, and support RBM activities.
• Maintain study-specific documentation and systems.
• Transmit documents to clients and centralized IRB/IEC.
• Maintain vendor trackers and support start-up team in regulatory submissions.
• Work with sites to obtain documents related to site selection.
• Assist in preparation of regulatory compliance review packages.
• Coordinate with internal departments to align site start-up activities.
• Document real-time communication and follow-up with site contacts.
• Review survey data for logical, complete responses.
• Collaborate with teammates to meet project deadlines and communicate site issues.
• Implement and ensure compliance with site contact plans, advancing concerns as needed.
• Serve as local expert on site capacity and experience, recommending additional sites.
• Liaise with Global Investigator Services to resolve queries and maintain contact information.
• Contribute to global strategic feasibility processes and development of standard methodologies.
• Train new personnel in processes and systems.
• Apply local knowledge to identify and develop new sites.

Education and Experience:

High/Secondary school diploma or equivalent. Bachelor’s degree or equivalent experience preferred.

Knowledge, Skills, and Abilities:

• Team-oriented with the ability to work independently.
• Exceptional organizational skills and attention to detail.
• Proven ability to manage multiple tasks efficiently.
• Strong customer focus and flexibility to adapt to changing project timelines.
• Proficient in MS Office and clinical trial database systems.
• Positive attitude, self-motivated, and strong interpersonal skills.
• Effective communication and negotiation skills.
• Skilled problem solver with excellent judgment and decision-making abilities.
• Skill in effectively managing risks and advancing them as needed.

Working Conditions and Environment:

• Work is performed in various environments, including office, laboratory, clinical, and home office settings.
• Occasional travel required.

** This position is remote.