Clinical Trial Coordinator

🔥 2 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%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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

• Provide administrative and technical support to the Project Team • Support audit readiness through scheduled file reviews • Provide administrative support for site activation activities • Aid development of site activation critical paths • Develop and review site lists for feasibility activities and provide local input into site tiering • Coordinate, oversee, and complete assigned trial activities according to the task matrix • Perform department, internal, country, and investigator file reviews and document findings • Ensure tasks are completed on time, within budget, and to quality standards • Provide system support for Activate and eTMF and keep databases current • Process documents for Client (e)TMF, perform (e)TMF reviews, distribute communications, and provide reports • Analyze and reconcile study metrics and findings reports • Assist with Investigator Site File and Pharmacy binder materials and study supplies • Support study-specific translation materials and translation quality control • Maintain knowledge of SOPs, client directives, and regulatory guidelines • Conduct on-site feasibility visits where applicable for Asia Pacific roles • Support scheduling of client and internal meetings • Review and track local regulatory documents • Support RBM activities and study documentation systems • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers • Support regulatory submissions and site selection document collection • Prepare regulatory compliance review packages • Coordinate with internal departments on site start-up activities • Complete Site Interest Plans in CTMS when applicable • Document site communications, follow-ups, and survey responses in real time • Review survey data for completeness and logical consistency • Collaborate with teammates and clinical personnel to address site issues and risks • Ensure effective site contact and follow-up plans and escalate non-compliance • Provide local expertise on site capacity and experience and recommend additional sites • 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 • Use local knowledge to identify and develop new sites

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Bachelor's degree preferred • Previous experience comparable to 0 to 1 year • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Ability to work in a team or independently • Good organizational skills and strong attention to detail • Ability to analyze project-specific data/systems • Flexibility to reprioritize workload • Working 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 (Word, Excel, and PowerPoint) • Ability to learn and master clinical trial database systems • Ability to complete the organization's clinical training program • Effective oral and written communication skills • Judgment and decision-making skills • Ability to follow project work instructions accurately • Good negotiation skills • Ability to manage risk and perform risk escalation appropriately • Occasional travel may be required • Occasional drives to site locations

🏖️ Benefits

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