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Clinical Trial Coordinator
Thermo Fisher Scientific. Provide administrative and technical support to the Project Team .
About the role
Key responsibilities & impact- Provide administrative and technical support to the Project Team
- Support audit readiness by ensuring files are reviewed according to organizational SOPs and department guidance
- Provide administrative support for site activation activities and aid development of the site activation critical path
- Develop and review site lists for feasibility activities and provide local input into site tiering
- 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 risks to project leads
- Provide system support for Activate and eTMF and keep system databases current
- Process documents to the Client eTMF, perform eTMF reviews, distribute communications, and provide documents and reports to internal team members
- Analyze and reconcile study metrics and findings reports; assist with resolving site documentation findings
- 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
- Maintain knowledge of SOPs, client directives, and regulatory guidelines
- Conduct on-site feasibility visits where applicable (Asia Pac only)
- Support client and internal meeting scheduling
- Review and track local regulatory documents where applicable
- Support RBM activities and study-specific documentation and systems
- Transmit documents to clients and centralized IRB/IEC
- Maintain vendor trackers
- Support regulatory submissions and site selection document collection
- Assist with regulatory compliance review packages and coordinate site start-up activities
- Complete Site Interest Plans in CTMS and document site contact, follow-up, and survey responses
- Review survey data for logical, complete, and accurate responses
- Collaborate with teammates and clinical personnel to meet deadlines and manage site issues and risks
- Maintain site contact and follow-up plans and escalate concerns or non-compliance
- Act as local expert on site capacity and experience, recommend additional sites, and support local site tiering
- Liaise with Global Investigator Services to resolve investigator queries and maintain account and contact information
- Contribute to global strategic feasibility processes and best practices
- Train new personnel in processes and systems
- Use local knowledge to identify and develop new sites
- May act as a buddy during onboarding and provide training to new staff
Requirements
What you’ll need- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year)
- Bachelor's degree preferred
- Ability to work in a team or independently as required
- Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
- Demonstrated ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Strong customer focus
- Flexibility to reprioritize workload to meet changing project timelines
- Working 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
- Good computer skills, proficient 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
- Essential judgment and decision-making skills
- Ability to accurately follow project work instructions
- Good negotiation skills
- Ability to manage risk and perform risk escalation appropriately
- Occasional driving to site locations and potential occasional travel
- In some cases, an equivalency consisting of appropriate education, training and/or directly related experience may be considered sufficient
Benefits
Comp & perks- Fully remote work arrangement
- Standard Monday–Friday work schedule