Clinical Trial Coordinator

🔥 0 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 risks to project leads • Provide system support for Activate and eTMF and keep system databases current • Process documents for the Client (e)TMF, perform (e)TMF reviews, distribute communications, and provide documents and reports • Analyze and reconcile study metrics and findings reports; assist with resolving site documentation findings • 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/internal meeting scheduling and tracking of local regulatory documents • Support RBM activities and study documentation, training requirements, system access, and project activity plans • Transmit documents to the client and centralized IRB/IEC • Maintain vendor trackers and support regulatory submissions • 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 associated investigator/site personnel documents as needed • 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 deadlines, site issues, and risks • Maintain an effective site-contact and follow-up plan; escalate concerns and 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/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 comparable to 0 to 1 year • Equivalency consisting 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 • Proficient in MS Office (Word, Excel, and PowerPoint) and ability to master clinical trial database systems • Ability to 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

🏖️ Benefits

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

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