Thermo Fisher Scientific Inc is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of 13 billion USD, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity™ Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management.
Post : Clinical Trial Coordinator I
Job Description
Discover Impactful Work :
Provides administrative and technical support. Supports audit readiness by ensuring files are reviewed according to the schedule detailed in the organization's SOP and department guidance document. Aids the development of the critical path for site activation within assigned projects in support of rapid site activations. May use local knowledge, organization systems, external site lists and sponsor directives to develop and review site lists that are suitable for the strategic needs of feasibility activities and to provide local input into the site tiering process.
A day in the Life :
• Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
• Ensures allocated tasks are performed on time, within budget and to a high-quality standard. Proactively communicates any risks to project leads.
• Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
• Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
• May support scheduling of client and/or internal meetings.
• May review and track of local regulatory documents.
• Maintains vendor trackers.
• Supports start-up team in Regulatory submissions.
• Works directly with sites to obtain documents related to site selection.
• Works in collaboration with teammates to achieve targeted goals for assigned projects. Connect with the team and appropriate clinical personnel regarding site issues and risks.
Candidate Profile
• Relevant formal academic / vocational qualification. Bachelor's degree preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6 months to 1 year).
• Ability to work in a team or independently as required
• Flexibility to reprioritize workload to meet changing project timelines
• Demonstrated ability to attain and maintain a solid understanding 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
• Good digital literacy, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
• Effective oral and written communication skills
• Crucial judgment and decision-making skills
• Capable of accurately following project work instructions
Additional Information :
Experience : Bachelor's degree preferred
Location : Remote, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Research
End Date : 30th October 2024
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