Clinical Research Monitor(CRA)

Join our dynamic team as a Clinical Research Monitor and play a pivotal role in advancing medical research. This position offers the flexibility of a virtual work environment, with a preference for candidates located in Colorado. Enjoy the convenience of working remotely while having the opportunity to travel extensively across the United States, supporting groundbreaking clinical trials.

Must Have Qualifications:

• Bachelor's degree
• Ability to travel up to 80%
• Proficiency in Microsoft Office Applications (Word, Excel, PowerPoint, etc.)
• Knowledge of FDA Regulations (21 CFR 812) and ISO 14155

Nice to Have Qualifications:

• Experience with CTMS, RAVE, VeeVa

Responsibilities:

• Monitor the progress of clinical trials at site level or headquarters, ensuring compliance with protocols, SOPs, GCP, and regulatory requirements.
• Develop and maintain relationships with clinical investigators, CROs, affiliated hospitals, and research institutions.
• Review adverse event cases with investigators, monitor timelines, budgets, and schedules, and prepare study documents and status reports.
• Assist with the design, development, and monitoring of clinical evaluation projects.
• Train investigators and site personnel, and implement clinical development strategies.
• Contact and recommend qualified investigators for studies and initiate clinical trials.
• Ensure recruitment and retention of patients.

Additional Information:

• This is a full-time position with a 40-hour work week.
• Work location is virtual, with a preference for candidates in Colorado to facilitate travel to both the West and East Coasts.
• Requires practical knowledge and demonstrated competence within the job area, typically obtained through advanced education combined with experience.
• Requires a University Degree and a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.