Clinical Trial Associate
- Assist in the coordination and management of clinical trials, including study start-up, maintenance, and close-out activities in close collaboration with Clinical Trial Managers and CRO.
- Maintain, organize, and update essential study documentation to ensure they are complete, accurate, and audit-ready at all times.
- Facilitate effective communication between study sites, clinical trial managers, and other stakeholders by managing correspondence, scheduling meetings, and distributing study-related information.
- Support the site start-up process including document collection, tracking and communication with CRO teams. Monitor site performance metrics and follow up on any outstanding issues.
- Assist in the preparation, submission, and tracking of regulatory documents to ensure compliance with local and international regulations (e.g., FDA, EMA, ICH-GCP).
- Collaborate with data management teams to track case report form (CRF) completion and query resolution. Ensure data is accurately captured and reported.
- Coordinate with external vendors (e.g., CROs, labs, etc.) to ensure timely delivery of services and supplies required for trial conduct.
- Assist in tracking trial budgets, manage study trackers and reports to ensure visibility into timelines and deliverables.
- Participate in monitoring activities and internal audits to ensure adherence to study protocols and regulatory requirements. Report findings and assist in implementing corrective actions as needed.
- Bachelor’s degree in life sciences, nursing, or a related field.
- 3+ years of experience in clinical research or related fields, with 1+ year of experience within the biopharmaceutical industry.
- Experience in oncology
- Strong understanding of ICH-GCP, clinical trial regulations, and start-up processes.
- Excellent organizational and time management skills with the ability to handle multiple priorities.
- Strong communication skills, both written and verbal, with the ability to work collaboratively in a small, fast-paced biotech environment.
- Proficiency in Microsoft Office Suite including strong skills in Excel
- Attention to detail and a commitment to maintaining high-quality standards.
- Ability to work independently and solve problems proactively.
- Previous experience working with contract research organizations (CROs) and external vendors, preferred
- Knowledge of clinical trial management systems (CTMS), electronic trial master file (eTMF) and electronic data capture (EDC) system, preferred
- Working knowledge of data management, query resolution, and supply chain logistics, preferred
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