Clinical Trial Coordinator I
Posted 21 days ago
You'll complete your application on Thermo Fisher Scientific's career site.
About the Role
As a Clinical Trial Coordinator I, you function as a key team member, delivering critical technical and administrative assistance to advance clinical research efforts. Your work is fundamental to upholding the rigorous quality and regulatory standards required in global clinical services. You will assist project teams throughout the entire study lifecycle, guaranteeing that trial operations are performed effectively and meet established objectives. This position provides a chance to operate in a dynamic, team-oriented setting focused on impactful therapies. You will interact with internal groups and site staff, applying your knowledge to assist with site initiation, regulatory adherence, and continuous study administration. This role is intended for detail-focused, self-driven individuals looking to cultivate specialized expertise in global research workflows and clinical trial management.
Requirements
- You should possess a Bachelor’s degree and roughly three years of professional clinical research background.
- You need proficiency in Microsoft Office tools such as Excel, Word, and PowerPoint, plus hands-on experience using eTMF platforms, ideally Veeva Vault.
- A robust grasp of organizational standard operating procedures, ICH Good Clinical Practices, and relevant local regulations is mandatory.
- You must have superior written and oral communication skills in both English and any required local languages.
- Candidates must exhibit excellent organizational capabilities, precision in detail, and the capacity to function effectively in cross-functional groups or independently.
- You are expected to evaluate project data for correctness, handle risk, and exercise sound judgment in decision-making.
- A flexible, service-oriented mindset is essential, as is the ability to adjust priorities in a fast-changing workplace.
- You must be ready to master various clinical trial databases and complete the mandatory internal clinical training curriculum.
Responsibilities
- You will deliver administrative aid for site initiation and participate in creating critical paths for site activation.
- Your role involves managing assigned trial tasks per the task matrix, ensuring completion adheres to budget, schedule, and quality benchmarks.
- Responsibilities include conducting internal, departmental, and investigator file audits, managing documentation for client eTMF platforms, and keeping study records current.
- You will work with colleagues to manage site-related challenges and risks, reporting issues to leadership as needed.
- You will organize materials for pharmacy binders and Investigator Site Files, while assisting with regulatory submissions by assembling compliance review dossiers.
- You will communicate with Global Investigator Services to handle questions, update site contact details, and guarantee data precision in study metrics via routine reporting.
- The position requires coordinating client and internal meetings, offering local insights regarding site capacity, and occasionally performing feasibility visits at sites within the Asia Pacific area.
- You will also engage in training incoming staff members and contribute to the development of feasibility processes and global best practices.
Benefits & Perks
- This role is performed entirely remotely, following a standard Monday to Friday work schedule.
Note: This listing is summarized and paraphrased by WorkNow from a publicly posted role. For the original wording and full details, please refer to the employer's official posting.
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