Clinical Trial Coordinator
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Job Description
Clinical Trial Coordinator supporting pharmaceutical and biotech clinical-trial administration, feasibility, and site activation in Brazil. Maintaining trial systems, regulatory documents, and investigator site files.
Responsibilities:
- 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 site activation critical paths.
- 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 databases current.
- Process and review eTMF documents, distribute communications, and provide documents and reports to internal team members.
- Analyze and reconcile study metrics and findings reports.
- Coordinate Investigator Site File and Pharmacy binder materials and non-clinical study supplies.
- Support study-specific translation materials and translation quality control.
- Review and track local regulatory documents and support regulatory submissions.
- Coordinate client and internal meetings as needed.
- Maintain study documentation, team lists, training requirements, system access, activity plans, vendor trackers, and contact information.
- Work directly with sites to obtain site-selection documents and support site interest plans and survey responses.
- Prepare regulatory compliance review packages.
- Coordinate with internal departments to align site start-up activities with the activation critical path.
- Communicate with clinical personnel regarding site issues and risks; escalate non-compliance.
- Act as a local expert on site capacity and experience and contribute to identifying and developing new sites.
- Liaise with Global Investigator Services to resolve investigator queries.
- Contribute to global strategic feasibility processes and best practices.
- Train new personnel in processes and systems.
Requirements:
- 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).
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
- 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
- Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
- 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 obtain knowledge and master all clinical trial database systems
- Ability to successfully complete the organizations clinical training program
- Self-motivated, positive attitude and good interpersonal skills
- Effective oral and written communication skills
- Essential judgment and decision-making skills
- Capable of accurately following project work instructions
- Good negotiation skills
- Independent thinker
- Ability to manage risk and perform risk escalation appropriately
- Occasional drives to site locations; potential occasional travel required
Benefits:
- Fully remote work arrangement
- Standard Monday–Friday work schedule
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