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Clinical Trial Coordinator
Thermo Fisher Scientific. Coordinate, oversee and complete assigned trial activities according to the task matrix .
About the role
Key responsibilities & impact- 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
- Communicate project risks proactively to project leads
- Provide support for Activate, eTMF and other clinical trial systems and keep databases current
- Process documents for the Client eTMF, perform eTMF reviews, distribute mailings and communications, and provide reports
- Analyze and reconcile study metrics and findings reports
- Assist with resolving site documentation findings
- Coordinate and distribute Investigator Site File and Pharmacy binder materials and non-clinical study supplies
- Support translation materials and translation quality control
- Maintain knowledge of SOPs, client directives and regulatory guidelines
- Conduct on-site feasibility visits where applicable for Asia Pacific roles
- Support client and internal meeting scheduling
- Review and track local regulatory documents
- Support RBM activities and study-specific documentation and systems
- Transmit documents to the client and centralized IRB/IEC
- Maintain vendor trackers
- Support regulatory submissions
- Obtain site-selection documents directly from sites
- Prepare regulatory compliance review packages
- Coordinate with internal departments to align site start-up activities with the activation critical path
- Complete Site Interest Plans in CTMS and collect associated investigator and site personnel documents when applicable
- Document communications, follow-ups and survey responses in real time
- Review survey data for logical, complete and relevant responses
- Collaborate with teammates and clinical personnel regarding site issues and risks
- Maintain an efficient site-contact and follow-up plan and escalate non-compliance
- Provide local expertise on site capacity and experience and recommend additional sites
- Liaise with Global Investigator Services to resolve investigator queries and maintain account and 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
What you’ll need- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Bachelor's degree preferred
- Previous experience comparable to 0 to 1 year
- Equivalent combination of appropriate education, training and/or 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
- Strong customer focus
- Flexibility to reprioritize workload
- Working knowledge of applicable country regulations, ICH Good Clinical Practices, 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 complete the organization's clinical training program
- Effective oral and written communication skills
- Judgment and decision-making skills
- Ability to accurately follow project work instructions
- Negotiation skills
- Ability to manage risk and perform risk escalation appropriately
- Occasional travel may be required
- Occasional drives to site locations
Benefits
Comp & perks- Fully remote work arrangement
- Standard Monday–Friday work schedule