Clinical Trial Coordinator

🔥 1 minute ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👻 Ghost score 15%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Provide administrative and technical support to the Project Team • Support audit readiness through scheduled department, internal, country, and investigator file reviews • Coordinate, oversee, and complete assigned trial activities according to the task matrix • Ensure allocated tasks are completed on time, within budget, and to a high-quality standard • Maintain current Activate and eTMF system databases • Process documents to the Client eTMF, perform eTMF reviews, distribute communications, and provide documents and reports • Analyze and reconcile study metrics and findings reports • Assist with resolving site documentation findings • Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies • Support translation materials and translation quality control • Support site activation activities and develop critical paths for rapid site activation • Develop and review site lists for feasibility activities and contribute to local site tiering • Support regulatory submissions and prepare regulatory compliance review packages • Work with sites to obtain site-selection documents • Coordinate with internal departments to align site start-up activities • Maintain study documentation, team lists, training requirements, system access, and project activity plans • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers • Document site communications, follow-ups, and survey responses in real time • Review survey data for logical and complete responses • Communicate site issues and risks to clinical personnel and escalate concerns or non-compliance • Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information • Contribute to global feasibility processes and best practices • Train new personnel in processes and systems • Conduct on-site feasibility visits where applicable in Asia Pacific • Support RBM activities and client/internal meeting scheduling where applicable

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Bachelor's degree preferred • 0 to 1 year of previous comparable experience • Combination of appropriate education, training and/or directly related experience may be considered as an equivalency • Good organizational skills and strong attention to detail • Ability to analyze project-specific data/systems • Knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs • Good English language and grammar skills and proficient local language skills as needed • Proficiency in MS Office, including Word, Excel, and PowerPoint • Ability to learn and master clinical trial database systems • Ability to complete the organization's clinical training program • Ability to work independently or as part of a team • Flexibility to reprioritize workload • Self-motivated with positive attitude and good interpersonal skills • Effective oral and written communication skills • Judgment and decision-making skills • Ability to accurately follow project work instructions • Good negotiation skills • Ability to manage risk and perform risk escalation appropriately • Occasional drives to site locations; potential occasional travel required

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Potential occasional travel required • Opportunity to act as a buddy during onboarding and provide training to new staff

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