Sr Clinical Research Spec - Exempt
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.