Global Clinical Trial Operations Specialist
hace 3 semanas
Tfs Healthscience is a leading global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. With expertise in full service-capabilities, resourcing, and Functional Service (FSP) solutions, we support our clients' goals.
The Clinical Trial Associate plays a crucial role in organizing and maintaining the Study Master File (SMF) and coordinating tasks during the study according to company policies, SOPs, and regulatory requirements.
Key Responsibilities: Collaborate with the Study Team to initiate, maintain, and close/finalize the SMF ensuring GCP compliance.Establish and maintain study information in Clinical Trial Management System (CTMS) as per delegation from PM/Lead CRA or CRA.Maintain electronic files.Set up the Investigator's File as directed by the CRA.Point of contact for SMF-related matters.Maintain the SMF as directed by the Lead CRA/Project Manager.Qualifications: Bachelor's Degree preferred.Knowledge of GCP/ICH guidelines.Excellent written and communication skills.Good organizational skills.Familiarity with software applications.Able to work efficiently in a fast-paced environment with changing priorities.
We offer a competitive annual salary of $63,500, comprehensive benefits, and opportunities for personal and professional growth in a rewarding environment. Our team values collaboration, innovation, and making a positive impact on patients' lives.
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