FSP Clinical Trial Coordinator I

🔥 18 hours ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Clinical Trial Coordinator

👻 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 a high-quality standard; communicate risks to project leads • Provide system support for Activate and eTMF and keep system databases current • Process documents for client eTMF, perform eTMF reviews, distribute mass mailings and communications, and provide documents and reports to internal team members • Analyze and reconcile study metrics and findings reports; assist with resolving site documentation findings • 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 • Conduct on-site feasibility visits where applicable for Asia Pacific projects • Support client and internal meeting scheduling • Review and track local regulatory documents and support RBM activities • Maintain study documentation and systems, including 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 site start-up activities • Work directly with sites to obtain site-selection documents • Prepare regulatory compliance review packages • Coordinate with internal departments to align site start-up activities with the site activation critical path • Complete Site Interest Plans in CTMS and collect and deliver associated investigator and site personnel documents • Document all site-contact communications, attempts, follow-ups, and survey responses in real time • Review survey data for logical, complete, and relevant responses • Collaborate with teammates and clinical personnel to meet project deadlines and address site issues and risks • Maintain efficient site-contact and follow-up plans; ensure compliance and escalate concerns or non-compliance • Act as a local expert on site capacity and experience and recommend additional sites • Liaise with Global Investigator Services to resolve investigator queries and maintain account and 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 providing the knowledge, skills, and abilities to perform the job, comparable to 0 to 1 year • Ability to work in a team or independently as required • Good organizational skills and strong attention to detail, with 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 to meet changing project timelines • 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) and ability to 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 • Independent thinking • Ability to manage risk and perform risk escalation appropriately • Occasional travel may be required • In some cases, an equivalency consisting of appropriate education, training and/or directly related experience may be considered sufficient

🏖️ Benefits

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