Clinical Trial Coordinator II

🕒 4 days ago

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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 client (e)TMF documents, perform (e)TMF reviews, distribute communications, and provide documents and reports • Review and track local regulatory documents • Analyze and reconcile study metrics and findings reports • Assist with clarification and resolution of site documentation findings • Maintain vendor trackers • Coordinate, compile, and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies • Support study-specific translation materials and translation quality control • Provide technical and administrative project support in collaboration with internal departments and team members • Maintain accurate trial status information in databases • Develop and maintain relationships with client local affiliates where applicable • Train new personnel in processes and systems • Support study documentation, systems, tools, trackers, training requirements, and system access management • Provide system support for Activate and eTMF and support RBM activities where applicable • Transmit documents to clients and centralized IRB/IEC where applicable • Attend kickoff meetings, take notes, and schedule or organize meetings and 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 and develop site lists from internal and external sources • Maintain investigator and site staff contact details in company systems • Complete Site Interest Plans in CTMS and document site communications and follow-up • Review survey data for logical, complete, and relevant responses • Collaborate with teammates and clinical personnel regarding site issues and risks • Ensure efficient site-contact and follow-up plans, escalating concerns or non-compliance • Act as a local expert on site capacity and experience and support local site tiering • Conduct physician and site personnel interviews regarding standard of care and protocol-level input • Liaise with Global Investigator Services to resolve investigator queries and maintain account and contact information • Contribute to global strategic feasibility processes and best practices

🎯 Requirements

• High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification • Bachelor's degree preferred • At least 2 years of comparable previous experience • Equivalent combination of appropriate education, training, and directly related experience may be considered • Ability to work independently or in a team • Strong organizational skills and attention to detail • Ability to manage multiple tasks efficiently and effectively • Ability to analyze project-specific data and systems for accuracy and efficiency • Strong customer focus • Flexibility and adaptability to changing project timelines • Working knowledge of applicable country regulations, ICH Good Clinical Practices, organization/client SOPs, and WPDs • Excellent English language and grammar skills and proficient local language skills as needed • Good presentation, negotiation, oral, and written communication skills • Excellent computer skills and proficiency in MS Office, including Word, Excel, and PowerPoint • Ability to learn and master clinical trial database systems and appropriate software • Ability to successfully complete the organization's clinical training program • Effective interpersonal skills and relationship-building ability • Strong documentation quality and attention to detail • 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 • Ability to manage risk and escalate risks appropriately

🏖️ Benefits

• Fully remote work arrangement • Full-time employment • Potential occasional travel • Accessibility/disability accommodations for the application, interview, and job functions • Equal employment opportunity