Clinical Trial Coordinator II

🔥 18 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

🦅 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 • Complete allocated tasks on time, within budget, and to quality standards; communicate risks to project leads and line manager • Process documents sent to the client eTMF, perform eTMF reviews, distribute mailings and communications, and provide reports to internal teams • Review and track local regulatory documents • Analyze and reconcile study metrics and findings reports; assist with resolving site-documentation findings • Maintain vendor trackers and study status information in databases • 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 • Provide technical and administrative project support with internal departments and team members • Maintain knowledge of SOPs, client directives, and regulatory guidelines • Maintain study documentation, team lists, training requirements, system access, activity plans, and eTMF schedules • Provide system support for Activate and eTMF and may support RBM activities • Transmit documents to clients and centralized IRB/IEC • Attend kickoff meetings, take notes, and support scheduling and meeting minutes • Coordinate with internal departments to align site start-up activities with the site activation critical path • Assist with regulatory compliance review packages and regulatory submissions • Obtain site-selection documents and develop site lists using internal and external research • Maintain investigator and site staff contact details in company systems • Complete Site Interest Plans in CTMS and document site communications and survey responses • Review survey data for logical, complete, and relevant responses • Collaborate with teammates and clinical personnel regarding site issues, risks, deadlines, and follow-up plans • Act as a local expert on site capacity and experience; support site tiering and recommend additional sites • Conduct physician and site-personnel interviews to obtain protocol-level input for trial optimization • 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 and support departmental process improvements

🎯 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 2 years • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • Ability to work independently or in a team environment • Strong organizational skills and attention to detail; ability to handle multiple tasks efficiently • Ability to analyze project-specific data and systems for accuracy and efficiency • Strong customer focus • Flexibility and adaptability to 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 • Proficiency in MS Office (Word, Excel, and PowerPoint) and ability to learn clinical trial database systems • Ability to successfully complete the organization's clinical training program • Effective oral and written communication skills, including communication with medical personnel • Strong interpersonal, negotiation, relationship-building, and risk-management skills • Basic medical/therapeutic area and medical terminology knowledge • Basic organizational, planning, and local health systems knowledge • Ability to work in a matrix environment • Ability to attain and maintain knowledge of GCP and applicable SOPs • Occasional driving to site locations and potential occasional travel • Bachelor's degree preferred

🏖️ Benefits

• Fully remote work arrangement • Full-time employment • Standard Monday–Friday work schedule