Clinical Trial Coordinator

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Coordinate, oversee, and complete assigned trial activities according to the task matrix • Perform department, internal, country, and investigator file reviews and document findings • Ensure allocated tasks are completed on time, within budget, and to quality standards • Communicate project risks to project leads and line manager • Maintain study documentation, team lists, training trackers, system access, and project activity plans • Keep the electronic Trial Master File up to date and provide GoBalto and eTMF system support • Support risk-based monitoring activities • Process trial documents, perform eTMF reviews, manage mailings and communications, and provide reports • Schedule and organize client/internal meetings and complete meeting minutes • Review and track local regulatory documents • Transmit documents to clients and centralized IRB/IEC • Analyze and reconcile study metrics and findings reports • Assist with resolving site documentation findings • Maintain vendor trackers • Assist with Investigator Site File and Pharmacy binder materials and study supplies • Assist with translation materials and translation quality control • Attend kickoff meetings and take notes when required • Serve as a study lead or cross-functional liaison as applicable • Support onboarding by acting as a buddy and training new staff • Support departmental and cross-functional process improvement initiatives

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 4 years • Bachelor's degree preferred • Ability to work in a team or independently as required • Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively • Proven ability to analyze project-specific data/systems to ensure accuracy and efficiency • Strong customer focus • Flexibility and adaptability to reprioritize workload and support changing project timelines • Working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs • Excellent English language and grammar skills and proficient local language skills as needed • Good presentation skills • Proficient in MS Office (Word, Excel, and PowerPoint) and ability to learn clinical trial database systems • Ability to successfully complete PPD clinical training program • Self-motivated, positive attitude, and strong interpersonal skills • Occasional driving to site locations and potential occasional travel

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule

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