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.