Entry-Level Clinical Research Associate - Clinical Study Coordinator Experience Required

Medpace, Inc.; Deutschland; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Benefits dieser Stelle

Flexible work hours across days

In-house travel agents

Ongoing training by in-house doctors

Work with international CRA team

Zusammenfassung

Medpace is seeking a Clinical Research Associate to advance drug and medical device development across Germany, Austria, and Switzerland. Through the PACE CRA Training Program you will receive comprehensive training and join a team focused on monitoring, regulatory tasks, and site management.

Expect opportunities to travel 60-70% within the DACH region, with training from in-house experts, and a clear path for career growth in a diverse, global CRO environment.

Qualifikationen

• Must have a minimum of a Bachelor’s degree in a health or science related field.
• Experience as a Clinical Research Coordinator (minimum 1 year).
• Ability to travel 60-70% to locations in the DACH region.
• Proficient knowledge of Microsoft Office.
• Must be detail-oriented and efficient in time management.
• Excellent verbal and written communication and presentation skills in German and English.

Aufgaben

• 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.
• On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward.
• 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.

Kenntnisse

German-English communication

Ausbildung

Bachelor’s degree in science/health

Tools

Microsoft Office

Jobbeschreibung

Job Summary

The Clinical Research Associate role at Medpace is offering the unique opportunity to have an exciting career in the research of drug and medical device development. For those with a Life Sciencedegree with clinical research experience who want to travel throughout Germany, Austria, Switzerland and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you!

PACE – MEDPACE CRA TRAINING PROGRAM

Medpace provides comprehensive initial and ongoing training, unmatched by other CROs.

Through our PACE Training Program, you will join other PAChieving CReXcellence:

• 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.

REWARDS

This role 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 and opportunity for significant travel bonus.

CRA PERKS:

• Flexible work hours across days within a week


• In-house travel agents


• Ongoing therapeutic training by our in-house physicians, who are medical and regulatory experts


• Opportunities to work with international team of CRAs

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;


• On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward;


• 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

• Must have a minimum of a Bachelor’s degree in a health or science related field;


• Experience as a Clinical Research Coordinator (minimum 1 year);


• Ability to travel 60-70% to locations in the DACH region;


• Proficient knowledge of Microsoft® Office;


• Must be detail-oriented and efficient in time management


• Excellent verbal and written communication and presentation skills in German and English.

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

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

Collaborative Culture

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  • 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

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  • 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

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  • 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.