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. 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
• Research Coordinators
• Research Nurses

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
• Research Coordinators
• Research Nurse

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 pa

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 team