Clinical Trial Coordinator - FSP Dedicated - UK

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

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.

Discover Impactful Work:

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.

A day in the Life:

1. Coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
2. Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
3. Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
4. Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
5. Performs administrative tasks on assigned trials, including timely processing of documents sent to Client (e)TMF as assigned.
6. Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
7. Assists with coordination, compilation and distribution of Investigator Site File (ISF) materials.
8. Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
9. May conduct on-site feasibility visits (APAC only).
10. May support scheduling of client and/or internal meetings.
11. May review and track local regulatory documents.
12. Supports start-up team in Regulatory submissions.
13. Works directly with sites to obtain documents related to site selection.
14. Documents in real time all communication related to site contact.
15. Ensures compliance with the plan and escalate concerns/non-compliance to management.

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 (comparable to 0 to 1 year).

Knowledge, Skills, Abilities

• Ability to work in a team or independently as required
• Good organizational skills and strong attention to detail
• Strong customer focus
• Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint)

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.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.