Clinical Trial Coordinator II
Not Disclosed•Full-TimeOn-site
location_on784, South 3rd Street, Wilmington, New Hanover County, North Carolina, 28401, United States
About the Team
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotech firms, spanning 2,700 clinical trials across 100+ countries in the last 5 years. Our team operates at the forefront of innovation, driving the execution of complex global studies that shape the future of medicine.
About the Role
As a Clinical Trial Coordinator II (Senior Clinical Study Associate), you will independently perform tasks related to the planning and execution of clinical studies, directly supporting the strategy defined in the Clinical Development Plan. This role is designed for a professional who thrives in a fast-paced environment and is ready to take ownership of critical day-to-day clinical study activities.
You will work under the general supervision of the FSP Manager, collaborating closely with Clinical Operations Managers, study teams, and Clinical Research Organizations (CROs). Your day-to-day impact includes ensuring regulatory inspection readiness, reviewing essential study documentation, and supporting risk-based monitoring. Whether managing high-complexity studies or coordinating across multiple therapeutic areas, you will be a key link in our global matrix environment, communicating effectively with internal departments and external vendors to ensure study success.
Hiring Process
Candidates selected for this role will be expected to demonstrate strong organizational skills and the ability to manage competing tasks. The interview process will assess your technical knowledge of GCP and regulatory standards, your proficiency with clinical systems, and your ability to collaborate within a global team.
Equal Opportunity
We are an equal opportunity employer committed to building a diverse and inclusive workforce. We consider qualified applicants regardless of background, race, gender, or other protected characteristics.
Work location
Work model: On-site
784, South 3rd Street, Wilmington, New Hanover County, North Carolina, 28401, United States
Wilmington, North Carolina
Key Responsibilities
- check_circleManage vendor contract administration and support study close-out financial reconciliation
- check_circleReview and approve study documentation including essential document packets and informed consent forms
- check_circleSupport and oversee risk-based monitoring activities for assigned clinical studies
- check_circleCollaborate with Clinical Operations Managers, study teams, and CROs to execute study activities
- check_circlePrepare materials and participate in regulatory inspections to ensure inspection readiness
- check_circleSupport clinical trial systems such as CTMS, TMF, and COMPASS for selected studies
- check_circleMaintain knowledge of clinical research systems, processes, and regulatory standards
Requirements
- verifiedBachelor's degree or equivalent international degree required
- verified2-4 years' experience in pharmaceutical industry, clinical research organization, or related role
- verifiedFluent business English (oral and written)
- verifiedStrong knowledge of MS Word, Excel, PowerPoint, and Outlook
- verifiedUnderstanding and application of GCP, Regional, ICH, and applicable regulatory standards
Nice to Have
Experience in Phase 2 and 3 studies and global/international studies. Experience working across multiple therapeutic areas (including oncology). Experience in the study start up field.
Similar Job Opportunities
Skills, education and keywords
Skills: GCP, Ich, MS Word, Excel, Powerpoint, Outlook, CTMS, TMF, Oncology, Phase 2.
Education: Bachelor's degree or equivalent international degree required.
Frequently asked questions about Clinical Trial Coordinator II at Thermo Fisher Scientific
What does a Clinical Trial Coordinator II at Thermo Fisher Scientific do?expand_more
A Clinical Trial Coordinator II at Thermo Fisher Scientific is responsible for the following: Manage vendor contract administration and support study close-out financial reconciliation; Review and approve study documentation including essential document packets and informed consent forms; Support and oversee risk-based monitoring activities for assigned clinical studies; and Collaborate with Clinical Operations Managers, study teams, and CROs to execute study activities.
What are the requirements for this Clinical Trial Coordinator II role?expand_more
To qualify for the Clinical Trial Coordinator II at Thermo Fisher Scientific position, applicants should have: Bachelor's degree or equivalent international degree required; 2-4 years' experience in pharmaceutical industry, clinical research organization, or related role; Fluent business English (oral and written); Strong knowledge of MS Word, Excel, PowerPoint, and Outlook; and Understanding and application of GCP, Regional, ICH, and applicable regulatory standards.
Where is the Clinical Trial Coordinator II role at Thermo Fisher Scientific located?expand_more
Clinical Trial Coordinator II at Thermo Fisher Scientific is based in 784, South 3rd Street, Wilmington, New Hanover County, North Carolina, 28401, United States. This is a on-site role.
Is this Clinical Trial Coordinator II job remote, hybrid, or on-site?expand_more
Thermo Fisher Scientific has listed this Clinical Trial Coordinator II role as on-site.
How much experience is required for this Clinical Trial Coordinator II role?expand_more
Clinical Trial Coordinator II at Thermo Fisher Scientific typically requires 2–4 years of relevant experience at the mid level level.
What skills do you need for the Clinical Trial Coordinator II role at Thermo Fisher Scientific?expand_more
Key skills for Clinical Trial Coordinator II at Thermo Fisher Scientific include GCP; Ich; MS Word; Excel; Powerpoint; Outlook; CTMS; and TMF.
What education is required for Clinical Trial Coordinator II at Thermo Fisher Scientific?expand_more
Educational requirements for this role: Bachelor's degree or equivalent international degree required.
What category does the Clinical Trial Coordinator II role belong to?expand_more
Clinical Trial Coordinator II at Thermo Fisher Scientific is part of the scientific & qa job category on Recrutus.