Clinical Research Associate (CRA), Dallas

About the Role

The Clinical Research Associate (CRA) position offers an exciting career within clinical research. This role is for individuals with medical and life science backgrounds looking to explore the research field, travel the US, and be part of a team bringing pharmaceutical and medical devices to market. This position is office-based in Dallas, Texas.

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.
• Verify medical record and research source documentation against case report form data, informing 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.
• Verify the investigator is enrolling only eligible subjects.
• Review regulatory documents.
• Manage medical device and/or investigational product/drug accountability and inventory.
• Verify and review 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.

Requirements & Tech Stack

• Ability to travel 60-70% to locations nationwide is required.
• A valid driver’s license and the ability to drive to monitoring sites.
• 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.
• Minimum 1 year healthcare-related work experience preferred.
• Familiarity with various backgrounds within medical, healthcare, and science-related fields including:
• Nursing
• Dietetics
• Nutrition Science
• Pharmaceutical/Device Sales Representative
• Physical and Occupational Therapists
• Biomedical/Chemical Engineer
• Public Health
• PhD/Post-Doc
• Pharm.D
• Health and Wellness Education Coordinators
• Research Assistants
• Clinical Research Coordinators

Medpace CRA Training Program (PACE®)

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 at Medpace?

• Exciting travel opportunities.
• Opportunity to 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.