Senior Clinical Research Associate

This is a fully remote position, open to applicants in Colorado.

📋 Description

• Assist in the execution of clinical studies for product development and validation.

• Establish strong relationships with clinical trial sites.

• Collaborate across various functions to ensure timely monitoring and audit preparedness both at the sponsor and site levels.

• Contribute to the creation of study reports and materials for regulatory submissions.

• Engage professionally and foster relationships with Investigators, site personnel, Institutional Review Boards (IRBs), and key opinion leaders.

• Create study documentation.

• Conduct site selection and qualification processes.

• Provide training and support to sites regarding study procedures.

• Oversee study compliance and carry out study closeout activities.

• Coordinate with monitors and data management teams to guarantee data quality and promptness.

• Contribute to enhancements in clinical study operations processes.

⛳️ Requirements

• Bachelor’s degree in a technical field with 5–8 years of relevant experience; alternatively, a Master’s degree with 2–5 years of comparable industry experience; or a PhD with 0–2 years of experience.

• Capability and discretion to operate with minimal supervision while planning and executing site study operations.

• Proficiency in effective communication with site staff, Principal Investigators, and internal study team members.

• Experience in cross-functional collaboration to achieve objectives.

• Strong foundation in Good Clinical Practice (GCP) and clinical study experience, including a background as a Clinical Research Associate (CRA).

• Ability to manage multiple studies simultaneously and collaborate efficiently with monitors.

• Familiarity with electronic data capture systems (EDC), Clinical Trial Management Systems (CTMS), and electronic trial master files (eTMF).

• Preferred experience with Continuous Glucose Monitoring (CGM) systems.

• Preferred experience in diabetes clinical trials related to insulin therapies, insulin pumps, or digital health technologies.

• Willingness to travel 15–25% of the time.

🏝️ Benefits

• A comprehensive benefits program.

• Opportunities for growth on a global scale.

• Access to career development through in-house training programs and/or qualified tuition reimbursement.

• An exciting and innovative organization that leads the industry, committed to employees, customers, and communities.