About the Opportunity
We are partnered with a biotechnology company that is seeking a Senior/Principal Clinical Research Associate to cover their Midwest region (MN, WI, IL). The CRA will be responsible for overall clinical site management, including site identification, feasibility, pre-study site evaluation, study start-up, site initiation, patient recruitment, monitoring, site close-out activities, inspection readiness and local regulatory and IRB/EC submissions of clinical studies at designated sites in accordance with study protocol(s), Standard Operating Procedures (SOPs), ICH-GCP guidelines and all applicable regulatory requirements.
The annual base salary range is $150,000 to $175,000. Actual compensation offered to the successful candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level, among other things. Details about eligibility for bonus compensation (if applicable) will be finalized at the time of offer.
Job Responsibilities
- Be responsible for the successful start-up, monitoring and execution of Phase I-IV studies at assigned clinical sites
- Perform clinical site management and monitoring activities in compliance with principles of ICH-GCP guidelines, SOPs, local laws and regulations, study protocol(s), applicable study plans and working guidelines
- Serve as primary point of contact for clinical sites through all phases from start-up to close-out of clinical studies
- Perform required monitoring, including required source data verification, and ensure site activities are conducted in established timelines
- Facilitate site budget and site contract negotiations and ensure timely finalization of the required clinical trial agreements for designated sites in collaboration with clinical program management and finance
- Facilitate and support investigator site audits and/or inspection activities as needed
Job Requirements
- Bachelor’s Degree in a Life Science discipline required
- Bachelor’s Degree in Nursing or RN a plus
- Minimum 3 years of direct site monitoring experience required
- Must be willing and able to travel up to 50-65%
