Clinical Trial Coordinator

🔥 2 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Clinical Trial Coordinator

👻 Ghost score 10%

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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 • Communicate project risks to project leads and line manager • Maintain study-specific documentation, systems, tools, trackers, and (e)TMF files • Provide system support, including GoBalto and eTMF • Support risk-based monitoring (RBM) activities • Perform trial administration, including document processing, (e)TMF reviews, mailings, communications, and reports • Schedule and organize client/internal meetings and complete meeting minutes • Review and track local regulatory documents • Transmit documents to the client and centralized IRB/IEC • Analyze and reconcile study metrics and findings reports; assist with resolving site documentation findings • Maintain vendor trackers • Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies • Assist with study-specific translation materials and translation quality control • Attend kick-off meetings and take notes when required • Act as a study lead or cross-functional liaison as needed • Buddy new hires during onboarding and provide training as needed • Support departmental and cross-functional process improvement initiatives

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Bachelor's degree preferred • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years) • In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role • Ability to work in a team or independently as required • Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively • Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency • Strong customer focus • Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines • Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout • Excellent English language and grammar skills and proficient local language skills as needed • Good presentation skills • Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems • Ability to successfully complete PPD clinical training program • Self-motivated, positive attitude with effective strong interpersonal skills

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