Entry-level Clinical Research Associate - Clinical Study Coordinator experience required

Medpace, Inc.; Heverlee; Hybride; EUR 42 000 - 64 000; Plein temps

Résumé du poste

Medpace, Inc. is seeking an Entry Clinical Research Associate to join our CRA training program and embark on a career in drug and medical device development. The role offers training through PACE and travel across sites, with potential for remote work after gaining experience.

Applicants should have a health or life science background, have 1+ year of clinical research exposure, and be fluent in English, Dutch, and French. A valid driver's license and MS Office familiarity are required.

Qualifications

• Minimum Bachelor of Science in Health or Life Science related field.
• 1+ year of clinical research experience with patient-facing responsibilities.
• Excellent command of English, Dutch and French.
• Willing to travel approximately 60-70% nationally.
• Valid driver’s license; familiar with Microsoft Office

Responsabilités

• Conduct qualification, initiation, monitoring, and closeout visits for research sites per protocol.
• Communicate with site staff including coordinators and physicians.
• Verify investigator qualifications, training, resources, and facilities.
• Verify data entry accuracy and ensure good documentation practices per SOPs, GCP, and regulators.
• Regulatory document review and accountability for devices/products; adverse event review.

Connaissances

Clinical research experience

Strong communication skills

Problem solving

Willingness to travel

Formation

Bachelor of Science in Health or Life Science-related field

Outils

Microsoft Office

Description du poste

Job Summary

The Entry 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
• PhD/Pharm.D candidates
• ResearchCoordinators
• 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.

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:

• Mid-sized CRO where you are not just a number
• Dynamic working environment, with varying responsibilities day-to day
• Expansive experience in multiple therapeutic areas
• Work within a team of therapeutic, medical and regulatory experts
• Internally designed propriety Clinical Trial Management System – one stop shop for EDC, IWRS, regulatory portal, visits reports, and more
• Defined CRA promotion and growth ladder with potential for mentoring and management advancements
• Opportunity to work from home once job experience is gained
• Competitive pay

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

We kindly ask you to send applications in English.

Qualifications

• Minimum Bachelor of Science in Health or Life Science related field;
• 1+ year of clinical research experience with direct patient-facing responsibility as a Clinical Research Coordinator, Clinical Study Coordinator or similar;
• Excellent command of English, Dutch and French;
• Strong communication and problem solving skills;
• Willing to travel approximately 60-70% nationally;
• Valid driver’s license; and
• Familiarity with Microsoft® Office

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

• Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture

• Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
• Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development

• Office based environment with on-site mentors
• Defined career paths with clear advancement opportunities
• Industry renowned onboarding and training programs designed to accelerate professional development
• Ongoing training and continuous learning opportunities throughout your career
• An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits

• Competitive compensation programs that recognize and reward performance
• Comprehensive health, wellness, retirement, and PTO benefits
• Office based culture with occasional WFH that provides flexibility for eligible positions after training
• Company-sponsored social events

Please note benefits may vary based on country.

What to Expect Next

A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.