[Work From Home] Thermo Fisher Scientific FSP Clinical Trial Coordinator

FSP Clinical Trial Coordinator I | Work From Home

About Thermo Fisher Scientific

As a Clinical Trial Coordinator I, you will provide administrative and technical support to the Project Team, ensuring audit readiness by reviewing files according to the schedule detailed in the organization’s SOP and department guidance document. Your role will support site activation activities and assist in developing the critical path for site activation within assigned projects.

Position Name: FSP Clinical Trial Coordinator I
Organization: Thermo Fisher Scientific
Qualification: B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences
Experience: 1 to 3 Years
Salary: ₹4.3 Lakhs to ₹5.5 Lakhs
Location: Remote

Responsibilities

• Coordinate, oversee, and complete functions on assigned trial activities as detailed on the task matrix.
• Perform department, internal, country, and investigator file reviews, documenting findings in appropriate systems.
• Ensure tasks are performed on time, within budget, and to a high-quality standard; communicate risks to project leads.
• Provide system support (e.g., Activate & eTMF) and ensure system databases are current.
• Perform administrative tasks, including processing documents, performing (e)TMF reviews, distributing communications, and providing documents/reports to internal team members.
• Analyze and reconcile study metrics and findings reports; assist with clarification and resolution of findings.
• Assist with the coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assist with study-specific translation materials and translation QC.
• Maintain knowledge of SOPs, client SOPs/directives, and regulatory guidelines.
• Conduct on-site feasibility visits (Asia Pac only) as applicable.
• Support scheduling of client/internal meetings and review/track local regulatory documents.
• Provide system support and support RBM activities.
• Maintain study-specific documentation and systems, including team lists, tracking project-specific training requirements, system access management, and tracking project-level activity plans.
• Transmit documents to clients and centralized IRB/IEC.
• Maintain vendor trackers.
• Support start-up team in regulatory submissions and work with sites to obtain documents related to site selection.
• Assist with the preparation of regulatory compliance review packages and coordinate with internal departments to ensure site start-up activities are aligned.
• Complete the ‘Site Interest Plan’ in CTMS and collect/deliver associated documents from investigators and site personnel.
• Document all communication and follow-up associated with site contact and survey responses.
• Support the review of survey data for logical, complete, and reflective responses.
• Collaborate with teammates to meet project deadlines and communicate site issues and risks.
• Ensure efficient site contact and follow-up plans, compliance, and escalate concerns to management.
• Act as a local expert regarding site capacity and experience, gathering knowledge base, and recommending additional sites.
• Liaise with Global Investigator Services to resolve investigator queries and maintain ‘accounts and contact’ information.
• Contribute to the development and roll-out of global strategic feasibility processes and best practices.
• Train new personnel in processes and systems and utilize local knowledge to contribute to the identification and development of new sites.

Knowledge, Skills, and Abilities

Education	Bachelor’s Degree in Life Science preferred.
Experience	1-3 years in CRC or CTC role.
Skills	Excellent business communication skills, good knowledge of eTMF and ICH GCP-related activities, ability to work independently or in a team, strong organizational skills and attention to detail, proven ability to handle multiple tasks efficiently, strong customer focus and flexibility to reprioritize workload, good English language and grammar skills; proficient local language skills as needed, good computer skills (MS Office) and ability to master clinical trial database systems, self-motivated with a positive attitude and good interpersonal skills, effective communication, judgment, and decision-making skills, good negotiation skills and ability to manage risk appropriately.

Preferred Candidates

• Candidates preferably from Mumbai and nearby locations.
• Should be able to join immediately.

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