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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 a high-quality standard; communicate risks to project leads
- Provide system support for Activate and eTMF and keep databases current
- Process documents for client eTMF, perform eTMF reviews, distribute mass mailings and communications, and provide documents and reports
- Analyze and reconcile study metrics and findings reports
- Assist with Investigator Site File and Pharmacy binder materials and non-clinical study supplies
- Assist with study-specific 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 where applicable
- Support risk-based monitoring activities
- Maintain study documentation and systems, including team lists, training requirements, system access, and activity plans
- Transmit documents to clients and centralized IRB/IEC
- Maintain vendor trackers
- Support regulatory submissions
- Work with sites to obtain site-selection documents
- Assist with 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 documents where applicable
- Document site 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 deadlines, site issues, and risks
- Maintain an effective site-contact and follow-up plan and escalate concerns or 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 providing the knowledge, skills, and abilities to perform the job, comparable to 0 to 1 year
- In some cases, an equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient
- Ability to work in a team or independently as required
- Good organizational skills and strong attention to detail, with 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 according to changing project timelines
- 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) and ability to learn clinical trial database systems
- Ability to successfully 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 appropriate risk escalation
- Potential occasional travel and occasional drives to site locations
Benefits
Comp & perks- Fully remote work arrangement
- Standard Monday–Friday work schedule