Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate) (LA)

Summary: Medpace is a full-service clinical contract research organization that provides clinical development services to the biotechnology, pharmaceutical, and medical device industries. They are seeking a Clinical Research Associate to conduct qualification, initiation, monitoring, and closeout visits at research sites, ensuring compliance with approved protocols and regulations. 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 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 - Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; and - Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance Required Qualifications: - Must have a minimum of a Bachelor's degree in a health or science related field - Experience as a Clinical Research Coordinator (minimum 1 year) - Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely - Must maintain a valid driver's license and the ability to drive to monitoring sites - Proficient knowledge of Microsoft® Office - Strong communication and presentation skills - Must be detail-oriented and efficient in time management Required Skills: Clinical Research Coordinator experience, Bachelor’s degree in health/science Important Skills: Microsoft Office proficiency Benefits: Medical, Dental, Vision, 401(k), Vacation policy, Sick days, Paid holidays, Work from home flexibility, Short-term disability, Long-term disability, Health savings and flexible savings accounts, Life and AD&D insurance, Pet insurance, Reimbursement for travel expenses (including food and gas allowance, rental cars, and hotel accommodations)