Clinical Research Associate

February 15

🐊 Florida – Remote

Although this job is listed in Florida, this company may be open to hiring remote in other states.

🌴 South Carolina – Remote

Although this job is listed in South Carolina, this company may be open to hiring remote in other states.

💵 $75k - $100k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

🦅 H1B Visa Sponsor

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MCRA

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MCRA is the leading global full-service medical device, diagnostics, and biologics CRO and consulting advisory firm. MCRA delivers to its client’s industry experience, integrating its six business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization. MCRA’s integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices and medical device cybersecurity. MCRA places particular emphasis on its expertise working with companies in all stages of development and throughout the technology life cycle by ushering technologies from the conceptual pre-clinical stage to market approval.

Clinical Affairs • Quality Assurance • Regulatory Affairs • Reimbursement • Healthcare Compliance

51 - 200 employees

📋 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. • Position Overview • 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.

🎯 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