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Experienced Clinical Research Associate

Medpace Brockport, New York, US

About the Role

Overview Location: Fully Home-based, anywhere in Sweden. Monitoring sites throughout Sweden. The Clinical Research Associate at Medpace is offering the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with medical and/or health/life science interest and background who want to explore the research field, travel the Nordic region, and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you! PACE – MEDPACE CRA TRAINING PROGRAM For those with monitoring experience, we offer a Fast PACE version of our training program to allow you to integrate into Medpace's processes seamlessly. UNEXPECTED REWARDS This role takes you on a journey through travel and excitement which will allow you to make a difference on a large scale through the enhancement of pharmaceuticals and medical devices. The CRA position provides many other distinctive advantages including: Dynamic working environment, with varying responsibilities day-to day Expansive experience in multiple therapeutic areas Work within a team of therapeutic and regulatory experts Defined CRA promotion and growth ladder with potential for mentoring and management advancements Please submit applications in English. Responsibilities Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol; Communication with the medical site staff including coordinators, clinical research physicians and their site staff; Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements; Verification that the investigator is enrolling only eligible subjects; Regulatory document review; Medical device and/or investigational product/drug accountability and inventory; Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Qualifications Minimum of a bachelor’s degree; Health or life science related field; 2 years direct monitoring experience; Willing to travel approximately 40-60% in Sweden; Familiarity with Microsoft® Office; and Strong communication and presentation skills. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Structured career paths with opportunities for professional growth Employee health and wellness initiatives Awards Recognized by Forbes as one of America\'s Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What To Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps. #J-18808-Ljbffr

Required Skills

clinical research monitoring GCP pharmacovigilance site visits

Keywords

CRA clinical research associate monitoring Sweden home-based

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