Atlas Search

Manage clinical sites through all phases of clinical trials including start-up, monitoring, patient recruitment, and close-out while ensuring compliance with regulatory guidelines. | Bachelor’s degree in Life Science required, 3+ years direct site monitoring experience, willingness to travel 50-65%, knowledge of ICH-GCP and regulatory compliance. | We are partnered with a biotechnology company seeking a Clinical Research Associate (Senior/Principal). The CRA will be responsible for overall clinical site management, including site identification, feasibility, pre-study site evaluation, study start-up, site initiation, patient recruitment, monitoring, site close-out activities, inspection readiness and local regulatory and IRB/EC submissions of clinical studies at designated sites in accordance with study protocol(s), Standard Operating Procedures (SOPs), ICH-GCP guidelines and all applicable regulatory requirements. Responsibilities: • Responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites. • Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines. • Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies. • Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines. • Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance. • Facilitate and support investigator site audits and/or inspection activities as needed. Requirements: • Bachelor’s Degree in a Life Science discipline required • Bachelor’s Degree in Nursing or RN a plus • Minimum 3 years of direct site monitoring experience required • Must be willing and able to travel up to 50-65%