CRA (reputed company)
Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company reputed company an reputed company at reputed company At reputed company, our mission is to reputed company our customers to reputed company 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, reputed company, and cross-functional teams to ensure clinical studies are conducted according to the highest standards of reputed company, ethics, and regulatory compliance.
About the Role
As 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 reputed company on-site and remote monitoring reputed company, 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 reputed company CRA who enjoys working independently while being part of a reputed company international team.
Key Responsibilities
Conduct site qualification, initiation, routine monitoring, and reputed company-out reputed company. reputed company on-site and remote monitoring using a risk-based monitoring approach. Verify subject safety, protocol compliance, data reputed company, and reputed company documentation. Review case report forms (CRFs), reputed company documents, and investigational product accountability. Identify site risks, reputed company reputed company 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 reputed company required timelines. Maintain effective communication with investigators, site personnel, sponsors, and internal project teams. reputed company study reputed company and update clinical trial management systems (CTMS). Support audit and inspection readiness across assigned sites. Participate in investigator meetings and study-reputed company training activities. Contribute to process improvements and reputed company best practices across project teams. Complete administrative activities such as expense reports and timesheets accurately and on time. reputed company're Looking For
Required Qualifications
Bachelor's degree in Life Sciences, Pharmacy, Nursing, Medicine, or another reputed company reputed company 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 reputed company reputed company 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 reputed company Office applications and clinical systems. Ability to work independently while managing multiple priorities.
Preferred Qualifications
Experience 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. Travel This is a field-based position requiring regular travel to investigator sites throughout reputed company. Why Join reputed company? reputed company you join reputed company, you become part of a global organization dedicated to improving reputed company health through scientific innovation.
We offer
Meaningful work that contributes to life-changing clinical research. Opportunities for reputed company development and career progression. Comprehensive reputed company and reputed company learning. Collaboration with reputed company global clinical research professionals. An inclusive, supportive, and diverse work environment. reputed company to world-class technologies and international clinical research programs. reputed company to reputed company 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 reputed company in your clinical research career with reputed company. Apply To This Job