Clinical Trial Coordinator

🔥 4 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

• Provide administrative and technical support to the Project Team • Support audit readiness by ensuring files are reviewed according to organizational SOPs and department guidance • Provide administrative support for site activation activities and aid development of the site activation critical path • Develop and review site lists for feasibility activities and provide local input into 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 a high-quality standard; communicate risks to project leads • Provide system support for Activate and eTMF and keep system databases current • Process documents to the Client eTMF, perform eTMF reviews, distribute 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 (Asia Pac only) • Support client and internal meeting scheduling • Review and track local regulatory documents where applicable • Support RBM activities and study-specific documentation and systems • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers • Support regulatory submissions and site selection document collection • Assist with regulatory compliance review packages and coordinate site start-up activities • Complete Site Interest Plans in CTMS and document site contact, follow-up, and survey responses • Review survey data for logical, complete, and accurate responses • Collaborate with teammates and clinical personnel to meet deadlines and manage site issues and risks • Maintain site contact and follow-up plans and escalate concerns or non-compliance • Act as local expert on site capacity and experience, recommend additional sites, and support local site tiering • 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 • May act as a buddy during onboarding and provide training to new staff

🎯 Requirements

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year) • Bachelor's degree preferred • Ability to work in a team or independently as required • Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively • Demonstrated ability to effectively analyze project-specific data/systems to ensure 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 • Good computer skills, proficient 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 • 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 • Occasional driving to site locations and potential occasional travel • 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

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