FSP Clinical Trial Coordinator I

🔥 21 hours ago

🇵🇭 Philippines – 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 • Provide system support for Activate and eTMF and keep databases current • Process documents for Client eTMF, perform eTMF reviews, distribute communications and provide 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 • Conduct on-site feasibility visits where applicable in Asia Pacific • Support client and internal meeting scheduling • Review and track local regulatory documents • Support risk-based monitoring activities • Maintain study documentation, team lists, training requirements, system access and activity plans • Transmit documents to the client and centralized IRB/IEC • Maintain vendor trackers • Support regulatory submissions and preparation of regulatory compliance review packages • Work directly with sites to obtain site-selection documents • Coordinate with internal departments to align site start-up activities • Complete Site Interest Plans and collect associated investigator and 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 • Escalate concerns and non-compliance to management • Provide local expertise on site capacity, experience and tiering • 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 • 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 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 analyze project-specific data/systems accurately and efficiently • Strong customer focus • Flexibility to reprioritize workload • 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 (Word, Excel and PowerPoint) • Ability to learn and 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 • Occasional travel may be required

🏖️ Benefits

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

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