Senior Clinical Research Associate
Advanced Clinical
- Minneapolis, MN
- Permanent
- Full-time
- The Sr. CRA is responsible for assisting with the execution of high-quality clinical studies and will focus on the oversight and monitoring of investigational sites to ensure compliance and assist with study management activities.
- The Senior CRA will be a key contributor to the company’s clinical department and primarily responsible for the site management of assigned clinical investigative sites.
- The Sr. CRA will assist with the implementation and execution of study protocols and associated study documents for clinical trials, including clinical monitoring of the organization study.
- This also includes the coordination of site activities from site start-up to site closure as needed.
- The Sr. CRA will participate as needed in study review meetings and attend scientific meetings and industry conferences as required.
- The Sr. CRA will also conduct site visits including Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close Out Visits.
- Experience in study start-up and oversight of a CRO is highly desired.
- Therapeutic experience in breast cancer, breast reconstruction, or breast aesthetics(preferred).
- Ability to travel, approximately 25-50% which may be more based on business need.
- Read, write, and speak fluent English; excellent verbal and written communication skills is a must, including presentation skills.
- Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations.
- Understanding of clinical trial management processes and systems, including monitoring, investigational product handling, data management, etc.
- Well-developed critical thinking skills, including but not limited to critical attitude, in-depth investigation for appropriate root cause analysis and decision-making.
- Ability to handle risk-based monitoring concepts and processes.
- Ability to maintain internal and external stakeholder focus through the utilization of good listening skills, attention to detail and the ability to perceive underlying issues.
- Effective social skills and professional demeanor and appearance
- Strong attention to detail