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 relevant regulations at each site.

• Maintain accurate documentation within CTMS and eTMF systems.

• Support and monitor training and compliance records for site staff.

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

• Assist in subject recruitment and retention efforts at the site level.

• 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.

• Aid in the management of site budgets and ensure timely payments to sites.

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

⛳️ Requirements

• A Bachelor’s degree in Life Sciences or an equivalent qualification, 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 sector.

• Experience in multiple therapeutic areas is preferred.

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

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

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

• Preference will be given to candidates residing in Dallas, Texas, near 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 assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

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