Sr Clinical Research Spec - Exempt
LanceSoft Inc - Denver, CO
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Join our dynamic team as a Senior Clinical Research Specialist and take your career to the next level with a role that offers flexibility and the opportunity to work remotely from Home Must Have Qualifications: Clinical Research industry experience Experience in study start-up and site activation Solid understanding of FDA regulations (21 CFR part 820) Strong site communications and management Nice to Have: Experience with Audit (e.g., BIMO) Key Responsibilities: Oversee, design, plan, and develop clinical evaluation research studies. Prepare and author protocols and patient record forms. Conduct registered and non-registered clinical studies of products that satisfy a medical need and/or offer commercial potential. Interpret results of clinical investigations for new drug devices or consumer applications. Resolve operational aspects of clinical trials in conjunction with project teams. Adhere to standard operating procedures (SOP), good clinical practice (GCP), and specific country regulations. Prepare clinical trial budgets and manage clinical supply operations, site, and vendor selection. Qualifications: Requires a University Degree and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years relevant experience. Advanced knowledge of the job area combining breadth and depth, typically obtained through advanced education combined with experience. Work Environment: This position offers the flexibility of remote work from Virtual, CO, allowing you to balance your professional and personal life effectively.
Created: 2026-04-19