Clinical Research Associate II

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

📋 Description

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

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

• Ensure adherence to ICH-GCP, SOPs, and regulatory standards at the site.

• Maintain accurate documentation within CTMS and eTMF systems.

• Support and monitor site staff training and compliance records.

• Oversee patient safety and guarantee prompt reporting of AEs, SAEs, and PQCs.

• Aid in subject recruitment and retention initiatives.

• Manage drug accountability and ensure proper storage, return, or disposal.

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

• Document site progress and escalate any risks or issues as needed.

• Assist with site budgets and payment processes where applicable.

• Work collaboratively with CTAs, LTMs, and CTMs.

⛳️ Requirements

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

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

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

• Experience in monitoring across various therapeutic areas.

• Strong knowledge of ICH-GCP, local regulatory requirements, and clinical systems such as CTMS and eTMF.

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

• Excellent communication skills, problem-solving abilities, and a collaborative team mindset.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans provided.

• Life insurance and disability coverage offered.

• Employee assistance programs and wellness resources available.

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