Home-Based Experienced CRA (Clinical Research Associate)- Bonus/Equity
Responsibilities
- Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol
- Communicate 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
- Audit and review of 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
Qualifications
- Clinical Research Associate Experience (minimum 1 year)
- Ability to travel 60-70% to locations nationwide is required
- Must have a minimum of a bachelor’s degree in a health or science related field
- Proficient knowledge of Microsoft® Office
- Strong communication and presentation skills
- Must be detail-oriented and efficient in time management
Medpace Overview
Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries.
Medpace Overview
Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.
Cincinnati Perks
- Flexible work environment
- Competitive PTO packages, starting at 20+ days
- Competitive compensation and benefits package
- Company-sponsored employee appreciation events
- Employee health and wellness initiatives
- Community involvement with local nonprofit organizations
- Discounts on local sports games, fitness gyms and attractions
- Modern, ecofriendly campus with an on-site fitness center
- Structured career paths with opportunities for professional growth
- Discounted tuition for UC online programs
Awards
- Named a Top Workplace in 2024 by The Cincinnati Enquirer
- Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
- Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility