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Clinical Trial Coordinator – Colombia (Remote)
Support pharmaceutical and biotechnology clinical trials remotely from Colombia. Coordinate site activation, regulatory documentation, feasibility activities, file reviews, and clinical trial systems.
विवरण
- Provide administrative and technical support to the Project Team
- Support audit readiness through scheduled file reviews aligned with SOPs and department guidance
- Provide administrative assistance for site activation activities
- Help establish critical paths for site activation
- Develop and review feasibility site lists and provide local input on site tiering
- Coordinate and complete assigned trial activities according to the task matrix
- Conduct department, internal, country, and investigator file reviews and document findings
- Complete assigned work on schedule, within budget, and to quality standards while communicating risks to project leads
- Support Activate and eTMF systems and maintain accurate databases
- Process client eTMF documents, conduct eTMF reviews, distribute communications, and prepare reports
- Analyze and reconcile study metrics and findings reports
- Assist with Investigator Site File and Pharmacy binder materials and non-clinical study supplies
- Support translation materials and perform translation quality control
- Conduct on-site feasibility visits where applicable in Asia Pacific
- Schedule client and internal meetings as needed
- Review and track local regulatory documents as required
- Support RBM activities and study-specific documentation and systems
- Transmit documents to the client and centralized IRB/IEC
- Maintain vendor tracking records
- Support regulatory submissions and site start-up activities
- Work with sites to obtain site-selection documents
- Prepare regulatory compliance review packages
- Coordinate with internal departments to align site start-up activities
- Complete Site Interest Plans in CTMS and collect related investigator and site documents as needed
- Record 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 on deadlines, site issues, and risks
- Maintain site contact and follow-up plans and escalate non-compliance
- Provide local insight into 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 on processes and systems
- Use local knowledge to identify and develop new sites
आवश्यकताएँ
- High school or secondary school diploma, or equivalent, plus relevant formal academic or vocational training
- Bachelor’s degree preferred
- Previous experience comparable to 0–1 year
- An equivalent combination of appropriate education, training, and directly related experience may be considered
- Ability to work effectively both independently and as part of a team
- Strong organization and attention to detail
- Ability to manage multiple tasks efficiently and effectively
- Ability to accurately analyze project-specific data and systems
- Strong customer focus
- Flexibility to reprioritize workload
- Working knowledge of applicable country regulations, ICH Good Clinical Practice, organizational or client SOPs, and WPDs
- Good English language and grammar skills
- Proficiency in the local language as required
- Proficiency with Microsoft Office, including Word, Excel, and PowerPoint
- Ability to learn and master clinical trial database systems
- Ability to successfully complete the organization’s clinical training program
- Effective verbal and written communication skills
- Sound judgment and decision-making ability
- Ability to follow project work instructions accurately
- Good negotiation skills
- Ability to manage risk and escalate risks appropriately
लाभ
- Fully remote work arrangement
- Full-time position
- Standard Monday-to-Friday schedule
- Occasional travel may be required
- Training and onboarding support
- Opportunity to work with global pharmaceutical and biotechnology companies
- Professional development through a clinical training program
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