Clinical Research Associate (Pharm D Candidates)

About the Role

Medpace is hiring Pharm D candidates for the Clinical Research Associate (CRA) role, offering an exciting career within clinical research. This opportunity is for individuals with Pharm D backgrounds looking to explore the research field, travel the US, and contribute to bringing pharmaceutical and medical devices to market. This position is office-based in Cincinnati, OH.

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 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 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.
• Communicate with 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 adhered to, and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements.
• Perform on-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through an integrated Clinical Trial Management System to identify site deviations/deficiencies and implement corrective/preventive actions to bring a site back into compliance and mitigate risks.
• Verify 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 offer suggestions for improvement.
• Complete monitoring reports and follow-up letters, including summaries of significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Requirements & Tech Stack

• Ability to travel 60-70% to locations nationwide is required.
• A valid driver’s license.
• Proficient knowledge of Microsoft Office.
• Strong communication and presentation skills.
• Detail-oriented and efficient in time management.

Qualifications

• Minimum of a Bachelor’s degree in a health or science-related field; Pharm D degree preferred.
• GCP (Good Clinical Practice) knowledge.