Experienced Clinical Research Associate

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 pharmaceuticals 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
• Pharmacy Technicians
• Pharmaceutical/Device Sales Representatives
• Biotech Engineers
• PhD/Pharm.D candidates
• Health and Wellness Coordinators
• Research Assistants.

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.
• 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.

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:

• 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

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

• Minimum of a bachelor’s degree; Health or life science related field preferred;
• Willing to travel approximately 20% nationally;
• Familiarity with Microsoft Office;
• Strong communication and presentation skills a plus.