Clinical Research Associate - CRA ID-14447
đź“‹ Description
• MCRA, an IQVIA business, is a leading medical device advisory firm and clinical research organization (CRO). • MCRA's value contribution rests within its industry experience at integrating five business value creators—regulatory, clinical research, reimbursement, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. • MCRA's integrated application of these key value-creating functions provides unparalleled expertise for its clients. • MCRA has offices in Washington, DC, Manchester, CT, New York, NY, and a global presence in Japan and Europe and serves more than 1500 clients globally. • Its core focus areas of therapeutic experience include orthopedics, spine, cardiovascular, neurology, digital health, diagnostic imaging, wound care, dental, general healthcare, robotics, and in vitro diagnostic (IVD) devices. • MCRA, an IQVIA Business is seeking a Clinical Research Associate to be a critical member of the clinical operations team. • The Clinical Research Associate will be responsible for management of assigned investigator sites and all monitoring activities for assigned studies. • Clinical affairs duties of this position must be executed in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.
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🎯 Requirements
• Bachelor's degree (B.A./B.S.) in life sciences, healthcare or a related scientific discipline or Registered Nurse/Allied Health Professional with clinical research experience. • 2+ years of clinical research experience required • Minimum of 1 year of direct, on-site clinical trial monitoring experience required • Medical device experience is a plus • Knowledge of ICH guidelines for GCP • Knowledge of clinical monitoring procedures and best practices • Experience using Electronic Data Capture (EDC) and clinical trial management systems • Strong written and verbal communication and presentation skills • Strong research, analytical, critical-thinking, and problem-solving skills • Proficiency with MS Office Suite (Outlook, Word, Ppt, Excel) and internet applications • Ability to read, write, speak, and understand English