Clinical Trial Coordinator I

🔥 11 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

• Provide administrative and technical support to the Project Team • Support audit readiness through scheduled file reviews according to SOPs and department guidance • Provide administrative support for site activation and help develop site activation critical paths • Develop and review site lists for feasibility activities and contribute local input to 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 • Complete allocated tasks on time, within budget, and to quality standards; communicate risks to project leads • Support Activate and eTMF systems 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 translation materials and translation quality control • Conduct on-site feasibility visits where applicable in Asia Pacific • Schedule client and internal meetings • Review and track local regulatory documents • Support risk-based monitoring activities and study documentation systems • Transmit documents to clients and centralized IRB/IEC • Maintain vendor trackers • Support regulatory submissions and prepare regulatory compliance review packages • Work with sites to obtain site-selection documents • Coordinate internal departments to align site start-up activities with the activation critical path • Document site contacts, follow-ups, survey responses, and associated communications in real time • Review survey data for logical, complete, and relevant responses • Collaborate with teammates and clinical personnel to address site issues and risks • Escalate concerns and non-compliance to management • Provide local expertise on site capacity and experience and recommend additional sites • 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

• Bachelor's Degree preferred • Approximately 3 years of clinical research experience preferred • Strong verbal and written communication skills • Practical, hands-on experience with eTMF systems, preferably Veeva Vault • Experience preparing accurate meeting minutes for large, cross-functional teams • Ability to work in a team or independently as required • Good organizational skills and strong attention to detail • Ability to analyze project-specific data/systems for accuracy and efficiency • Strong customer focus • Flexibility to reprioritize workload • 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 • Proficiency in MS Office (Word, Excel, and PowerPoint) • Ability to learn and master clinical trial database systems • Ability to successfully complete the organization's clinical training program • Self-motivated, positive attitude, and good interpersonal 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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