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Experienced Clinical Research Associate

Medpace Holdings, Inc.

Spain, Madrid

Job Summary

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
  • Casual Dress Code

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;
  • 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 Spanish and English.
  • Excellent time management and organization skills;

Job posted: 2023-02-20

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