• Job Description

  Req#: 11456

  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.

  What can Medpace offer you?

  • Interesting projects, career advancement, and recognition and exposure to our international footprint;
  • Flexible working conditions – Opportunity to work from home and flexible working hours;
  • Competitive employee benefits;
  • Annual Merit increases;
  • Fast PACE® – Accelerated, tailored training program training program based on your experience;
  • Opportunity for cross-functional and CRA leadership positions – Lead CRA, CRA Manager, Clinical Trial Manager.

  
  Responsibilities
  
  

  As a CRA, you will specifically be responsible for the following:

  • 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;
  • 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 university degree in a health or life science related field;
  • 1.5 years’ work experience as a CRA;
  • Oncology monitoring experience would be an advantage;
  • Willing to travel approximately 60-80% nationally;
  • Familiarity with Microsoft® Office;
  • Must be detail-oriented and efficient in time management;
  • Strong communication and presentation skills a plus;
  • Proven track record of demonstrating experience in clinical patient management, protocol, CRF, preparing of ISF, documentation to be submitted to competent authorities.
  • Excellent verbal - written communication skills and excellent negotiations skills in Portuguese and English.

  • Excellent time management and organization skills.

  We kindly ask to submit your application in English.

  
  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?
  
  

  People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

  The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

  Medpace Perks

  • Flexible work environment
  • Competitive compensation and benefits package
  • Competitive PTO packages
  • Structured career paths with opportunities for professional growth
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives

  Awards

  • Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

  What to Expect Next

  A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

  
  

  • Must have a minimum of a university degree in a health or life science related field;
  • 1.5 years’ work experience as a CRA;
  • Oncology monitoring experience would be an advantage;
  • Willing to travel approximately 60-80% nationally;
  • Familiarity with Microsoft® Office;
  • Must be detail-oriented and efficient in time management;
  • Strong communication and presentation skills a plus;
  • Proven track record of demonstrating experience in clinical patient management, protocol, CRF, preparing of ISF, documentation to be submitted to competent authorities.
  • Excellent verbal - written communication skills and excellent negotiations skills in Portuguese and English.

  • Excellent time management and organization skills.

  We kindly ask to submit your application in English.

  
  

  As a CRA, you will specifically be responsible for the following:

  • 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;
  • Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

• About the company

  Medpace Holdings, Inc. is a midsize, clinical contract research organization based in Cincinnati, Ohio.

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