Clinical Trial Coordinator II

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Clinical Trial Coordinator

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

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 • Process documents sent to the client eTMF, perform eTMF reviews, distribute mass mailings, and provide documents and reports to internal team members • Review and track local regulatory documents • Analyze and reconcile study metrics and findings reports • Maintain vendor trackers • Assist with compiling and distributing Investigator Site File and Pharmacy binder materials and non-clinical study supplies • Assist with study-specific translation materials and translation quality control • Provide technical and administrative project support in collaboration with internal departments and team members • Maintain knowledge of SOPs, client directives, and applicable regulatory guidelines • Maintain accurate and current trial status information in databases • Develop and maintain relationships with client local affiliates where applicable • Support inclusion of Strategic Collaboration sites • Conduct on-site feasibility visits where applicable in Asia Pacific • Train new personnel in processes and systems • Maintain study documentation, team lists, training requirements, system access, and activity plans • Provide system support for Activate and eTMF • Support risk-based monitoring activities • Transmit documents to clients and centralized IRB/IEC • Attend kick-off meetings and take notes when required • Schedule and organize client/internal meetings and complete meeting minutes • Coordinate with internal departments to align site start-up activities with the site activation critical path • Assist with regulatory compliance review packages and regulatory submissions • Obtain site-selection documents directly from sites when needed • Develop site lists and maintain investigator/site staff contact details • Complete Site Interest Plans in CTMS and document site communications and survey responses • Review survey data for logical, complete, and relevant responses • Collaborate with teammates on deadlines, site issues, and risks • Plan and monitor site contact and follow-up, escalating concerns and non-compliance • Serve as a local expert on site capacity and experience and support site tiering • Conduct phone interviews with physicians and site personnel to obtain protocol-level input • Liaise with Global Investigator Services to resolve investigator queries and maintain account/contact information • Contribute to global strategic feasibility processes and best practices

🎯 Requirements

• Bachelor's degree preferred • Previous experience in a CTC role comparable to at least 2 years as a CTC • Experience in Veeva eTMF and CTMS • Experience working on global clinical trials and coordinating with local/global team members • Vendor Management experience preferred • Ability to work independently or in a team environment • Strong organizational skills and attention to detail • Ability to analyze project-specific data and systems • Strong customer focus • Flexibility and adaptability to changing project timelines • Working knowledge of applicable country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs • Excellent English language and grammar skills and proficient local language skills as needed • Good presentation skills • Proficiency in MS Office (Word, Excel, 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, including communication with medical personnel • Good negotiation skills • Basic medical/therapeutic area and medical terminology knowledge • Basic organizational and planning skills • Basic knowledge of local health systems • Working knowledge of GCP and applicable SOPs • Ability to work in a matrix environment • Relationship-building ability • Ability to manage risk and perform appropriate risk escalation

🏖️ Benefits

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