Sr CRA (Level II)
Remote · Not stated
Hiring locations: Remote, Georgia
Open posting at Thermo Fisher ScientificCheck the posting for country and time zone requirements before applying.
Employer’s description
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior Clinical Research Associate – Make an Impact at the Forefront of Innovation At 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 100+ countries. As a Senior Clinical Research Associate (CRA), Level I, you'll play an important role in the successful delivery of clinical trials, working closely with investigational sites, sponsors, and cross-functional project teams. You'll manage and coordinate all aspects of clinical monitoring and site management, conducting both remote and on-site visits to ensure trials are performed in accordance with approved protocols, ICH-GCP, applicable regulations, and company and sponsor procedures. As a trusted partner to investigational sites, you'll help safeguard patient rights and well-being while ensuring the quality and reliability of clinical trial data. What You'll Do Clinical Monitoring & Site Management • Perform remote and on-site monitoring activities using a risk-based monitoring approach. • Conduct Source Data Review (SDR), Source Data Verification (SDV), and CRF review, as applicable, to ensure data quality and accuracy. • Assess investigational product accountability through inventory and records review. • Apply critical thinking, root-cause analysis, and problem-solving techniques to identify site process issues and implement appropriate corrective and preventive actions. • Identify, document, escalate, and follow through on site deficiencies and issues until resolution. • Maintain regular communication with investigational sites between monitoring visits to support protocol compliance, timely data entry, and issue resolution. • Conduct monitoring activities in accordance with approved monitoring plans. Study Delivery & Compliance • Ensure clinical trials are conducted in accordance with approved protocols, ICH-GCP, applicable regulations, and relevant SOPs and procedures. • Ensure essential study documents are complete, accurate, and maintained according to regulatory requirements. • Conduct on-site file reviews according to project requirements and support ongoing audit and inspection readiness. • Initiate clinical trial sites and support site close-out activities, including the retrieval of study materials. • Participate in investigator meetings and support the identification and assessment of potential investigational sites. • Respond to company, sponsor, and applicable regulatory audit and inspection requirements. Project Collaboration • Provide study status and progress updates to the Clinical Team Manager (CTM). • Maintain accurate and timely information in study systems, including the Clinical Trial Management System (CTMS). • Perform quality checks of CTMS-generated reports where required. • Facilitate effective communication between investigational sites, sponsors, and the wider project team. • Contribute to project tools, communications, and publications and share ideas and best practices with colleagues. • Support additional study activities as assigned, which may include trip report reviews, newsletters, or leading CRA team calls. • Participate in investigator payment processes as required. • Contribute to project and cross-functional process improvement initiatives. • Complete required administrative activities, including expense reports and timesheets, accurately and on time. What We're Looking For Minimum Qualifications • Bachelor's degree in a life sciences-related field, Registered Nursing qualification, or equivalent relevant academic/vocational qualification. • At least 2+ years of experience as a Clinical Research Monitor / CRA, or comparable relevant experience. • Valid driver's license, where applicable. • Equivalent combinations of education, training, and directly related experience may also be considered. Preferred Skills & Experience • Strong clinical monitoring and site management skills. • Excellent understanding and practical application of ICH-GCP, applicable regulations, and clinical research procedures. • Good knowledge of medical terminology and relevant therapeutic areas. • Experience applying Risk-Based Monitoring (RBM) principles and processes. • Strong critical thinking, root-cause analysis, and problem-solving capabilities. • Excellent attention to detail with strong organizational and time-management skills. • Effective written and verbal communication skills, including the ability to communicate confidently with medical professionals and investigational site staff. • Strong interpersonal skills and a collaborative, customer-focused approach. • Ability to adapt to changing priorities and work effectively both independently and as part of a global team. • Proficiency in Microsoft Office and the ability to quickly learn clinical trial systems and software. • Good written and spoken English. • Strong presentation skills. Working Environment & Travel This is a field-based clinical monitoring role that requires regular travel to investigational sites. • Frequent travel is required, typically 60–80%, depending on study and business needs. • Regular driving to clinical trial sites may be required. • Travel may include extended and overnight stays. • Work may be performed in home-office, office, laboratory, and clinical environments. • The role may involve exposure to biological materials in clinical environments, with appropriate personal protective equipment provided or required. • You will be expected to comply with applicable sponsor, client, and investigational site requirements. Why Join Thermo Fisher Scientific? When you join Thermo Fisher Scientific, you become part of a global team committed to accelerating scientific discovery and improving patient outcomes. We offer: • The opportunity to work on innovative and diverse global clinical research programs. • Exposure to a broad range of sponsors, therapeutic areas, and clinical trial environments. • A collaborative and inclusive culture where your expertise and ideas are valued. • Continuous learning, professional development, and opportunities for career progression. • Competitive compensation and benefits. • The opportunity to make a meaningful contribution to clinical research and the development of therapies that can improve patients' lives. If you're an experienced CRA who enjoys building strong relationships with investigational sites, solving complex challenges, and ensuring the highest standards of clinical trial quality, we'd love to hear from you. Apply today and help us deliver tomorrow's breakthroughs.