Clinical Research Associate II

This is a fully remote position, open to applicants in California, +3 more states.

📋 Description

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

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

• Ensure that sites adhere to ICH-GCP, SOPs, and applicable regulations.

• Maintain documentation within CTMS and eTMF systems.

• Assist in training site staff and keep compliance records up to date.

• Monitor patient safety and manage AE/SAE/PQC reporting.

• Aid in subject recruitment and retention efforts.

• Supervise drug accountability and the processes of storage, return, or destruction.

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

• Record site progress and escalate any risks or issues that arise.

• Help manage site budgets and payment processes.

• Collaborate with CTAs, LTMs, and CTMs.

⛳️ Requirements

• A Bachelor's degree in Life Sciences or a related field, or a qualified RN.

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

• Minimum of 2 years of on-site monitoring experience in the pharmaceutical or CRO sector.

• Experience in multiple therapeutic areas is preferred.

• Proficient in ICH-GCP, local regulatory requirements, CTMS, and eTMF.

• Willingness and ability to travel up to 50% for on-site monitoring visits throughout the northwest region.

• Preference given to candidates residing in the Pacific Northwest, Utah, or Northern California near major HUB airports.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

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