1 week ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. Job Details About We are seeking an experienced and detail-oriented Clinical Research Associate to lead and manage clinical trials from initiation through close-out. The CRA will play a critical role in ensuring clinical study integrity, compliance with GCP, and successful execution of study activities across multiple sites. This position requires a strong understanding of regulatory requirements and the ability to work independently in a fast-paced, cross-functional environment. Qualifications Bachelor's degree in life science/related field, advanced degree preferred Minimum of 2+ years in clinical research industry Solid understanding of GCP guidelines, regulatory requirements (e.g., Medsafe, TGA), and clinical trial processes Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams. Detail-oriented with the ability to work in a fast-changing environment. Excellent interpersonal, oral, and written communication skills. Superior organizational skills with attention to details. Ability to work with little or no supervision. Responsibilities Manage multiple clinical trials from initiation to close-out, ensuring adherence to study protocols, timelines, and budgets. Develop and update study tracking documents: subject tracking, essential document tracking, and sample collection/management. Conduct site visits to monitor study progress, evaluate data quality, and ensure compliance with GCP when needed. Gather, track, and review site regulatory documents for TMF filing. Perform data verification and query resolution to ensure data integrity and accuracy. Facilitate tracking of clinical lab samples and central reader/lab data, including shipments and reconciliation. Provide guidance and training to junior CRAs and site staff on study protocols and procedures. Collaborate with regulatory affairs to ensure proper documentation submission. Work closely with clinical operations, data management, and biostatistics teams for effective communication. Identify potential issues and develop mitigation strategies. Travel as needed. Skills Strong attention to detail Good written and verbal communication Organized and able to manage multiple tasks Reliable and self-motivated Ability to work independently or in a team Friendly and professional with clinical site staff What We Offer Competitive salary Opportunity to work on cutting-edge projects Supportive and dynamic work environment Professional development and growth opportunities Additional Information Founded in 2005, KlinEra is a global leader in clinical trial services, with a presence on every major continent and headquarters in Silicon Valley. We focus on ethical and efficient trials across therapeutic areas like gastroenterology, oncology, and neurology. We are committed to community initiatives and providing affordable medical care. Join our team if our mission resonates with you. Location: San Jose, California Languages English Seniority level Mid-Senior level Employment type Full-time Job function Research, Analyst, and Information Technology Industries Technology, Information and Internet #J-18808-Ljbffr TieTalent
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