Principal Clinical Trial Monitor

Clinical Research Associate Role Overview We are currently seeking a highly skilled Clinical Research Associate to join our team. This role plays a pivotal part in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. Key Responsibilities: Conduct onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes. Verify the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations. Ensure the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations, and SOPs. Manage investigative site staff to facilitate trial deliverables, such as subject enrollment, data deliverables. Verify proper management and accountability of Investigational Product (IP). Write and submit reports of investigational site findings and updates applicable tracking systems. Escalate observed deficiencies, issues, and corrective and preventative action plans as appropriate. Manage essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; assist with resolution of investigational site/data queries. Perform key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation. Participate in audit preparation and follow-up activities as needed. Independently perform various onsite and offsite monitoring visit types. Gather and review information for assigned sites and identify inconsistencies. With limited guidance from project and functional management, assess risk and escalate as appropriate. Assist with non-complex adhoc, short-term assignments in support of additional studies or departmental initiatives. May serve as preceptor, providing training to less experienced clinical team members. Required qualifications include an undergraduate degree or international equivalent in a clinical, science, or health-related field from an accredited institution and health care professional licensure, i.e., registered nurse. Previous experience supporting clinical trials, including solid onsite monitoring experience in CROs or pharma companies. Travel is required 50-80%. Benefits and Opportunities: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, you'll enjoy a range of benefits designed to promote well-being and work-life balance opportunities for you and your family. At our organization, inclusion and belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. Our workplace is free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. If you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please let us know. Why You'll Thrive Here: If you're passionate about making a difference in healthcare and advancing innovative treatments and therapies, this role offers exciting opportunities for growth and development. As a Clinical Research Associate, you'll play a critical part in shaping the future of healthcare and working collaboratively with talented professionals who share your passion and commitment to excellence.