Clinical Research Associate

Functieomschrijving

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 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 varied backgrounds in medical and other science-related healthcare fields. Individuals who have succeeded in the CRA role include:

- Nurses
- Dieticians
- Pharmacists
- Biomedical researchers
- Pharmaceutical/Device Sales Representatives
- Biotech Engineers
- Research Coordinators
- Research Nurses
- PACE_ - MEDPACE CRA TRAINING PROGRAM

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 Professionals Achieving CRA Excellence:

- _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.

**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;
- 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; and
- Maintain close collaboration, interaction, and effective working relationships with international Medpace internal cross-functional teams.

Profiel

**Qualifications**:

- Minimum Bachelor of Science in Health or Life Science related field
- Broad knowledge of the local language (Dutch and French) and excellent English;
- Willing to travel approximately 60-70% nationally;
- Familiarity with Microsoft® Office;
- Strong communication and presentation skills; and
- Valid driver’s license

Jobgerelateerde competenties
- Onderzoeksgegevens en -resultaten bestuderen en analyseren
- Methodes voor onderzoek en voor de gegevensverzameling en -analyse bepalen en ontwikkelen
- Rapporten, publicaties en scripties opstellen
- Discipline: Biowetenschappen
- Discipline: Medische wetenschappen
- Wetenschappelijke, technologische, technische, reglementaire,informatie opvolgen en actualiseren
- Onderzoekers, instituten, ondernemingen adviseren en wetenschappelijke steun bieden
- Het verloop en de vooruitgang van wetenschappelijke experimenten en observaties leiden en controleren

Persoonsgebonden competenties
- Plannen en organiseren
- Creativiteit
- Communiceren
- Verantwoordelijkheid
- Resultaatgerichtheid
- Analyseren
- Digitaal denken
- Diversiteit
- Kritisch denken
- Zelfstandigheid
- Samenwerken
- Flexibiliteit
- Klantgerichtheid

Aanbod

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.

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 yo