Clinical Research Associate - Clinical Research Coordinator Experience

Medpace - Cincinnati, OH

Full-time - Mid Level

Remote - Cincinnati, OH

1,001-5,000 employees

Professional, Scientific, and Technical Services

About the position

The Clinical Research Associate (CRA) position at Medpace is designed for clinical research professionals with at least one year of Clinical Research Coordinator experience. This role involves conducting various monitoring visits at research sites, ensuring compliance with protocols, and providing training and support to site staff. The position offers the opportunity to work from home and includes a comprehensive training program to develop into a fully functional CRA.

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.
• Perform medical record and research source documentation verification against case report form data, ensuring good documentation practices are adhered to and communicating protocol deviations appropriately.
• Engage in on-site and virtual/remote monitoring activities with a risk-based monitoring approach to identify site deviations/deficiencies and corrective/preventive actions.
• Verify that the investigator is enrolling only eligible subjects.
• Review regulatory documents and ensure compliance with protocols.
• Account for medical devices and investigational products/drugs, including inventory management.
• Verify and review adverse events, serious adverse events, concomitant medications, and corresponding illnesses for accurate data reporting.
• Assess the clinical research site's patient recruitment and retention success and offer suggestions for improvement.
• Complete monitoring reports and follow-up letters summarizing significant findings, deviations, deficiencies, and recommended actions.

Requirements

• Bachelor's degree in a health or science related field.
• Minimum of 1 year experience as a Clinical Research Coordinator.
• Ability to travel 60-70% to locations nationwide, with some visits conducted remotely.
• Valid driver's license and ability to drive to monitoring sites.
• Proficient knowledge of Microsoft® Office.
• Strong communication and presentation skills.
• Detail-oriented and efficient in time management.

Benefits

• Competitive travel bonus
• Equity/Stock Option Program
• Training completion and retention bonus
• Annual merit increases
• 401K matching
• Opportunity to work from home
• Flexible work hours across days within a week
• Home office furniture allowance, laptop, mobile phone with hotspot for internet access
• In-house travel agents and reimbursement for airline club and TSA pre-check
• Opportunities for leadership positions
• Ongoing therapeutic training by in-house physicians
• In-house administrative support for CRAs
• Opportunities to work with an international team of CRAs