Clinical Research Associate

1 mese 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

Pharm.D candidates

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;

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;

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 completed (as per DMC 15/11/2011)

Fluent in English and Italian language;

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 internal growth opportunities.

Organic Growth: Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarter's campus includes five buildings and approximately 600,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO.

Perks ( vary by location and position ):

On-site fitness center(s)

Campus walking paths

Company-sponsored social and wellness events

Official Sponsor of FC Cincinnati

Hybrid work-from-home options and flexible work schedule

On-site Market Place

Free and covered parking

Discounts for local businesses

On campus restaurants and banks coming soon

Awards:

Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer

Recognized by Forbes as one of America's Best Mid-size Companies in 2021

Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability

Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

Ranked in the top 10 on the 2021 LinkedIn Top Companies list in Cincinnati

What to Expect Next:

A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.

EO/AA Employer M/F/Disability/Vets

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