CRA / Sr CRA

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate (CRA / Sr. CRA) At Thermo Fisher Scientific, our Clinical Research team supports leading pharmaceutical, biotechnology, and emerging biopharma companies in advancing innovative therapies worldwide. Having contributed to thousands of clinical trials across more than 100 countries, we are committed to accelerating research that improves patient lives. As a Clinical Research Associate (CRA), you will play a key role in the monitoring and management of clinical trial sites, ensuring compliance with study protocols, ICH-GCP guidelines, regulatory requirements, and company procedures. Working closely with investigative sites and cross-functional teams, you will help safeguard patient safety, data integrity, and overall study quality while supporting the successful delivery of clinical research programs. Position Summary As a Clinical Research Associate (CRA), you will be responsible for performing and coordinating clinical monitoring and site management activities across clinical trials. You will conduct remote and on-site monitoring visits, ensure compliance with study protocols, ICH-GCP guidelines, applicable regulations, and SOPs, while safeguarding subject safety, data integrity, and audit readiness. You will collaborate closely with investigational sites, sponsors, and cross-functional project teams to support the successful execution of clinical studies. Key Responsibilities: Conduct on-site and remote monitoring visits using a risk-based monitoring approach. Review source documentation, case report forms (CRFs), and study data to ensure accuracy, completeness, and compliance. Perform site management activities, including site initiation, routine monitoring, and close-out visits. Assess investigational product accountability through inventory and records review. Identify site process issues, perform root cause analysis, and support implementation of corrective and preventive actions. Ensure essential documents are maintained in accordance with ICH-GCP and regulatory requirements. Prepare monitoring reports, follow-up letters, and study documentation within established timelines. Maintain effective communication with investigational sites, sponsors, and internal study teams. Support site identification, feasibility, and investigator engagement activities when applicable. Track study progress and maintain accurate records in clinical trial management systems (CTMS) and other study tools. Support regulatory inspections, audits, and quality initiatives. Contribute to process improvements, project deliverables, and knowledge sharing across teams. Minimum Qualifications: Bachelor’s degree in Life Sciences, Nursing, or a related healthcare field, or an equivalent combination of education and experience. Valid driver’s license, where applicable. Ability to travel as required. Experience: Relevant clinical research and/or clinical monitoring experience in a pharmaceutical, biotechnology, CRO, or healthcare environment. Candidates may be considered for CRA or Sr CRA opportunities based on their experience, qualifications, and demonstrated monitoring expertise. Preferred Skills & Competencies: Knowledge of ICH-GCP guidelines, clinical trial processes, and applicable regulations. Understanding of medical terminology and therapeutic areas. Strong critical thinking, problem-solving, and root cause analysis skills. Experience with Risk-Based Monitoring (RBM) methodologies. Excellent organizational and time management skills. Strong written and verbal communication skills, including professional interaction with investigators and site personnel. Ability to work independently and collaboratively in a global team environment. Proficiency with Microsoft Office and clinical trial systems. Strong attention to detail and commitment to quality. English proficiency required. Working Conditions and Environment • Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment. • Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays. • Exposure to biological fluids with potential exposure to infectious organisms. • Personal protective equipment required such as protective eyewear, garments and gloves. • Exposure to fluctuating and/or extreme temperatures on rare occasions.