Clinical Trial Coordinator

🔥 18 hours ago

🇲🇽 Mexico – 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 clinical 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 quality standards • Provide system support for Activate and eTMF and keep databases current • Process trial documents, perform eTMF reviews, distribute communications and provide reports • Analyze and reconcile study metrics and findings reports • Coordinate and distribute Investigator Site File, 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 local regulatory document tracking • Support risk-based monitoring activities and study documentation systems • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers and support regulatory submissions • Obtain site-selection documents directly from sites • Prepare regulatory compliance review packages • Coordinate site start-up activities with internal departments • Complete Site Interest Plans and collect associated investigator/site 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 on site issues, risks and deadlines • Develop and maintain efficient site contact and follow-up plans • Provide local expertise on site capacity, experience and tiering • Resolve investigator queries with Global Investigator Services and maintain account/contact information • Contribute to global 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 • Equivalent combination of appropriate education, training and/or directly related experience may be considered • Ability to work independently or in a team • Strong organizational skills and attention to detail • Ability to analyze project-specific data and systems • Strong customer focus • Ability to reprioritize workload according to changing timelines • Working knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs and WPDs • Good English language and grammar skills and proficient local language skills as needed • Proficiency in MS Office, including Word, Excel and PowerPoint • Ability to learn and master clinical trial database systems • Ability to successfully complete the organization's clinical training program • Effective oral and written communication skills • Judgment and decision-making skills • Ability to follow project work instructions accurately • Negotiation skills • Ability to manage risk and escalate risks appropriately

🏖️ Benefits

• Fully remote work arrangement • Full-time employment • Standard Monday–Friday work schedule • Potential occasional travel • Clinical training program

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