Clinical Research Associate

2 giorni fa

Milano, Italia Medpace, Inc. A tempo pieno

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 field and 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 of therapeutic 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 site's 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 5,000 people across 40+ countries.
Why Medpace?
:
When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices.
Our employees provide hope for those living with debilitating diseases.
We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and i

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