Join our team as a Senior Clinical Trial Coordinator (Safety Reporting) and be part of our mission to deliver innovative health solutions. This role is critical in ensuring comprehensive trial and site administration, primarily focusing on safety reporting. You will have the opportunity to collaborate closely with various teams and contribute to continuous improvement initiatives. If you are passionate about clinical research and have a proactive attitude towards problem-solving, we encourage you to apply.
Responsibilities
Trial and site administration: tracking essential documents including safety reports, ensuring collation and distribution of study tools and documents, updating clinical trial databases and trackers.
Document management: preparing documents and correspondence, collating, distributing/shipping, and archiving clinical documents, assisting with eTMF reconciliation, executing eTMF Quality Control Plan.
Regulatory & Site Start-Up responsibilities: providing to and collecting from investigators forms/lists for site evaluation/validation, site start-up and submissions, supporting preparation of safety report submission package for IRB/ERC and supporting regulatory agencies submissions.
Quality & Oversight: contributing to CTC team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required, mentoring junior CTCs.
Qualifications Required
Minimum 3 - 5 years in Clinical Research or relevant healthcare experience.
Bachelor's Degree.
Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills.
Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
Hands on knowledge of Good Documentation Practices.
Good IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
ICH-GCP Knowledge appropriate to role.
Highly effective time management, organizational and interpersonal skills, conflict management.
Effective communication with external customers (e.g. sites and investigators).
High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
Demonstrates commitment to Customer focus, both internally and externally.
Able to work independently taking full ownership of delegated tasks.
Proactive attitude to solving problems / proposing solutions.
Positive mindset, growth mindset.
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