CRA Level I

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Clinical Research Associate I – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you’ll have the opportunity to perform and coordinate different aspects of the clinical monitoring and site management process. As a Clinical Research Associate I, you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix. What You’ll Do: Perform and coordinates different aspects of the clinical monitoring and site management process. Conduct remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manage procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). Act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensure audit readiness. Develops collaborative relationships with investigational sites. Qualifications: Education and Experience: Bachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification. Minimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered. Valid driver's license.