CRA (Level II)

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Make an Impact at Thermo Fisher ScientificAt Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. Over the past five years, we have supported the world's top 50 pharmaceutical companies and more than 750 biotechnology organizations, contributing to over 2,700 clinical trials across more than 100 countries. As part of our Clinical Research team, you'll play a key role in advancing innovative therapies that improve patients' lives worldwide. You'll collaborate with investigators, healthcare professionals, and cross-functional teams to ensure clinical studies are conducted according to the highest standards of quality, ethics, and regulatory compliance. About the RoleAs a Clinical Research Associate II (CRA II), you will independently manage assigned clinical trial sites, ensuring studies are conducted in accordance with study protocols, ICH-GCP guidelines, local regulations, and sponsor requirements. You will perform on-site and remote monitoring visits, build strong relationships with investigators and site staff, identify and resolve site issues, and contribute to the successful delivery of global clinical trials. This is an excellent opportunity for an experienced CRA who enjoys working independently while being part of a collaborative international team. Key ResponsibilitiesConduct site qualification, initiation, routine monitoring, and close-out visits. Perform on-site and remote monitoring using a risk-based monitoring approach. Verify subject safety, protocol compliance, data quality, and source documentation. Review case report forms (CRFs), source documents, and investigational product accountability. Identify site risks, perform root cause analysis, and implement corrective and preventive actions. Ensure essential study documentation is complete and maintained in accordance with ICH-GCP and regulatory requirements. Prepare accurate monitoring reports and follow-up letters within required timelines. Maintain effective communication with investigators, site personnel, sponsors, and internal project teams. Track study progress and update clinical trial management systems (CTMS). Support audit and inspection readiness across assigned sites. Participate in investigator meetings and study-related training activities. Contribute to process improvements and share best practices across project teams. Complete administrative activities such as expense reports and timesheets accurately and on time. What We're Looking ForRequired QualificationsBachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, or another related healthcare discipline. At least one year of independent clinical monitoring experience as a Clinical Research Associate, or successful completion of the PPD Drug Development Fellowship. Good understanding of ICH-GCP guidelines and applicable regulatory requirements. Experience performing on-site monitoring visits within clinical trials. Strong organizational and time management skills. Excellent written and verbal communication skills in English. Strong analytical thinking, problem-solving, and decision-making abilities. Ability to build productive relationships with investigators and study teams. Good knowledge of Microsoft Office applications and clinical systems. Ability to work independently while managing multiple priorities. Preferred QualificationsExperience working across multiple therapeutic areas. Experience with Risk-Based Monitoring (RBM). Knowledge of Clinical Trial Management Systems (CTMS) and electronic Trial Master File (eTMF) systems. Experience supporting regulatory inspections or sponsor audits. TravelThis is a field-based position requiring regular travel to investigator sites throughout Georgia. Why Join Thermo Fisher Scientific?When you join Thermo Fisher Scientific, you become part of a global organization dedicated to improving human health through scientific innovation. We offer: Meaningful work that contributes to life-changing clinical research. Opportunities for professional development and career progression. Comprehensive onboarding and continuous learning. Collaboration with experienced global clinical research professionals. An inclusive, supportive, and diverse work environment. Access to world-class technologies and international clinical research programs. Ready to Make a Difference?If you're passionate about clinical research and want to help bring innovative therapies to patients around the world, we'd love to hear from you. Apply today and take the next step in your clinical research career with Thermo Fisher Scientific.