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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
- Complete allocated tasks on time, within budget, and to quality standards
- Provide system support for Activate and eTMF and maintain current databases
- Process documents sent to the Client eTMF, perform eTMF reviews, distribute communications, and provide reports
- Analyze and reconcile study metrics and findings reports
- Assist with Investigator Site File and Pharmacy binder materials and study supplies
- Support translation materials and translation quality control
- Maintain knowledge of SOPs, client directives, and regulatory guidelines
- 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 and site start-up activities
- Obtain site-selection documents directly from sites
- Prepare regulatory compliance review packages
- Complete Site Interest Plans in CTMS and collect associated documents
- Document site communications, follow-ups, and survey responses in real time
- Review survey data for logical, complete, and accurate responses
- Collaborate with teammates and clinical personnel regarding site issues and risks
- Maintain site-contact plans and escalate concerns or non-compliance
- Provide local expertise on site capacity and experience and recommend additional sites
- Resolve investigator queries and maintain account and contact information
- Contribute to global feasibility processes and best practices
- Train new personnel in processes and systems
- Contribute local knowledge to identifying and developing new sites
- Conduct on-site feasibility visits where applicable in Asia Pacific
- Occasional driving to site locations and potential travel
Requirements
What you’ll need- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Previous experience comparable to 0 to 1 year
- Bachelor's degree preferred
- Equivalent combination of appropriate education, training and/or directly related experience may be considered
- Ability to work in a team or independently
- Good organizational skills and strong attention to detail
- Ability to handle multiple tasks efficiently and effectively
- Ability to analyze project-specific data/systems for accuracy and efficiency
- Strong customer focus
- Flexibility to reprioritize workload
- Knowledge 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
- 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 follow project work instructions accurately
- Good negotiation skills
- Ability to manage risk and perform risk escalation appropriately
Benefits
Comp & perks- Fully Remote work arrangement
- Standard Monday–Friday work schedule