Clinical Research Associate

About the Role

Join our CRA Team in Dallas, TX! We are hiring those with Biomedical Engineering backgrounds for the CRA role! The Clinical Research Associate position offers an exciting career within clinical research. This position is office based in Dallas, TX.

Medpace CRA Training Program (PACE®)

No prior research experience is needed, as Medpace provides comprehensive initial and ongoing training. The PACE® (Professionals Achieving CRA Excellence) Training Program includes:

• A platform to effectively and confidently carry out CRA duties to ultimately become a high-functioning, independent, Medpace CRA
• Interactive discussions with hands-on exercises and practicums
• Core departmental rotations to learn various aspects of the drug/device development and approval process

Why CRA?

• Exciting travel opportunities
• Make a difference on a larger scale through the development of medical drugs and devices
• Dynamic working environment with varying day-to-day responsibilities
• Exposure to multiple therapeutic areas
• Defined CRA promotion and growth ladder

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

Requirements & Tech Stack

• Minimum of a Bachelor’s degree in a health or science related field; degree in Biomedical Engineering preferred
• Ability to travel 60-70% to locations nationwide is required
• A valid driver’s license and the ability to drive to monitoring sites
• Minimum 1 year healthcare-related work experience preferred
• Proficient knowledge of Microsoft Office
• Strong communication and presentation skills
• Detail-oriented and efficient in time management