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

Medpace is a full-service clinical contract research organization providing clinical development services to the biotechnology, pharmaceutical, and medical device industries. The company is seeking experienced Clinical Research Coordinators to transition into home-based Clinical Research Associate roles through its PACE® training program, conducting site monitoring, regulatory review, data verification, and compliance activities.

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 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
• Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance

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
• Retain airline reward miles and hotel reward points
• Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere
• In-house travel agents, reimbursement for airline club membership, and TSA pre-check
• Opportunity for leadership positions – Lead CRA, CRA Manager, Training and Development Manager, and many more
• CRA training program - PACE®
• Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts
• In-house administrative support for all levels of CRA
• Opportunity to work with international team of CRAs
• Office based environment with on-site mentors
• Defined career paths with clear advancement opportunities
• Industry renowned onboarding and training programs designed to accelerate professional development
• Ongoing training and continuous learning opportunities throughout your career
• Comprehensive health, wellness, retirement, and PTO benefits
• Office based culture with occasional WFH that provides flexibility for eligible positions after training
• Company-sponsored social events

Company

• Full-service clinical research organization for biotech, pharma, and medical devices
• Cincinnati, Ohio, USA
• http://www.medpace.com/
• Founded in 1992
• 5001-10000 employees

Qualifications

• Minimum of a Bachelor's degree in a health or science related field
• Experience as a Clinical Research Coordinator (minimum 2 years)
• Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely
• 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

Required skills

Experience

• 2+ years