Senior Clinical Research Associate

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.

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

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

• Manage documentation within CTMS and eTMF systems.

• Provide training for site staff and uphold compliance records.

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

• Assist in subject recruitment and retention efforts.

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

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

• Record site progress and escalate any risks or issues as necessary.

• Help manage site budgets and payment processes.

• Collaborate effectively with CTAs, LTMs, and CTMs.

⛳️ Requirements

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

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

• Minimum of 3 years of on-site monitoring experience within the pharmaceutical or CRO sector.

• Experience in various therapeutic areas is preferred.

• Strong knowledge of ICH-GCP, local regulatory standards, CTMS, and eTMF.

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

• Excellent communication, problem-solving, and teamwork abilities.

🏝️ 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.