FSP Clinical Trial Coordinator

🔥 0 minutes ago

🇧🇷 Brazil – 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

• Provide administrative and technical support to the Project Team • Support audit readiness through scheduled file reviews according to SOPs and department guidance • Provide administrative support for site activation activities and contribute to site activation critical paths • Develop and review site lists for feasibility activities and contribute local input to 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 allocated tasks are completed on time, within budget, and to quality standards; communicate risks to project leads • Provide system support for Activate and eTMF and maintain current databases • Process documents for client eTMF, perform eTMF reviews, distribute communications, and provide documents and reports • Analyze and reconcile study metrics and findings reports • Coordinate 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 RBM activities and study-specific documentation and systems • Transmit documents to the client and centralized IRB/IEC • Maintain vendor trackers • Support regulatory submissions and site selection document collection • 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 associated investigator/site personnel documents • Document site communications, follow-ups, 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 • Maintain site contact and follow-up plans 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 feasibility processes and best practices • Train new personnel in processes and systems • Utilize 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 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 • Self-motivated, positive attitude, and good interpersonal skills • 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 appropriate risk escalation

🏖️ Benefits

• Fully remote work arrangement • Standard Monday-Friday work schedule • Potential occasional travel • Training provided for new personnel and clinical training program