Clinical Research Associate – Cross Therapeutic Area

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

📋 Description

• Act as the main liaison between investigational sites and the sponsor.

• Perform site selection, initiation, routine monitoring, and close-out visits.

• Ensure compliance of sites with ICH-GCP, SOPs, and relevant regulations.

• Maintain accurate documentation within CTMS and eTMF systems.

• Assist in tracking site staff training and compliance records.

• Monitor patient safety and guarantee prompt reporting of AE/SAE/PQC.

• Aid in subject recruitment and retention strategies.

• Manage drug accountability, storage, return, or destruction processes.

• Address data queries and promote timely, high-quality data entry.

• Record site progress and escalate any risks or issues to the clinical team.

• Help with site budgets and ensure timely site payments when applicable.

• Collaborate with CTAs, LTMs, CTMs, and other cross-functional team members.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or equivalent, or a qualified RN.

• Must be eligible to work in the United States without visa sponsorship.

• A minimum of 2 years of on-site monitoring experience in the pharmaceutical or CRO industry.

• Experienced in monitoring across various therapeutic areas.

• Knowledgeable in ICH-GCP, local regulatory requirements, and clinical systems such as CTMS and eTMF.

• Willingness to travel 60% - 75% for on-site monitoring visits throughout the western region.

• Preference for candidates residing in Denver, close to major HUB airports to facilitate efficient regional travel.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.