FSP Clinical Trial Coordinator

🔥 1 minute 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

• 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 a high-quality standard • Provide system support for Activate and eTMF and keep system databases current • Process documents for the Client eTMF, perform eTMF reviews, distribute communications, and provide reports • Analyze and reconcile study metrics and findings reports • Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies • Support study-specific translation materials and translation quality control • Maintain knowledge of SOPs, client directives, and regulatory guidelines • Support client and internal meeting scheduling • Review and track local regulatory documents • Support risk-based monitoring activities and study documentation systems • Maintain study team lists, training requirements, system access, and project activity plans • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers • Support regulatory submissions and regulatory compliance review packages • Work with sites to obtain site-selection documents • Coordinate internal departments to align site start-up activities with the activation critical path • Complete Site Interest Plans in CTMS and collect associated investigator/site documents • Document communications, follow-up, and survey responses in real time • Review survey data for logical, complete, and relevant responses • Collaborate with teammates and clinical personnel regarding site issues and risks • Ensure site-contact and follow-up plans are implemented and escalate concerns or 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 strategic 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 • Equivalent 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 handle multiple tasks efficiently and effectively • Ability to analyze project-specific data/systems for accuracy and efficiency • Strong customer focus • 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 successfully complete the organization's clinical training program • Effective oral and written communication skills • Essential judgment and decision-making skills • Ability to accurately follow project work instructions • Good negotiation skills • Ability to manage risk and perform risk escalation appropriately

🏖️ Benefits

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