Clinical Research Associate

4 giorni fa

Lombardia, Italia Confidenziale A tempo pieno

Clinical Research Associate Job Locations Italy-Milan Category Clinical Research Associate Job Summary The Clinical Research Associate position at Medpace offers 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 a medical and/or health/life science background who want to explore the research fieldand be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you
Our successful Clinical Research Associates possess various backgrounds in medical and other science-related healthcare fields. Backgrounds of individuals who have succeeded in the CRA role include:
Nursing
Dietetics
Pharmacist
Pharmaceutical/Device Sales Representative
Biomedical/Chemical Engineer
PhD/Post-Doc
Health and Wellness Coordinators
Clinical Research Coordinators
Research Assistants
MEDPACE CRA TRAINING PROGRAM ( PACE )
No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE Training Program, you will join other P rofessionals A chieving C RA E xcellence:
PACE provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA.
PACE will prepare you by developing your CRA skills through interactive discussions and hands on job-related exercises and practicums.
To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process.
WHY BECOME A CRA
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 oftherapeutic and regulatory experts
Defined CRA promotion and growth ladder with potential for mentoring and management advancements
Competitive pay.
Bonus for CRA with 1,5 - 5 years of monitoring experience.
Responsibilities Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol;
Communication with the medical site staff including coordinators, clinical research physicians, and their site staff;
Verify 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;
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;
Assess the clinical research sites patient recruitment and retention success and offering suggestions for improvement; and
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 Master degree in health-related field;
Willing to travel 60-80% nationally;
Familiarity with Microsoft Office;
CRA certification
Fluent in English and Italian language; and
Strong communication and presentation skills a plus.
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 4,000 people across almost 40 countries.

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