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Job #03484

About our client Our client is a young venture-backed medical device company headquartered in Minnesota that is focused on the development and commercialization of innovative chronic wound care products. The organization has an experienced management team, significant revenue momentum and strong institutional financing to fund future development. This is a unique opportunity for someone that wants to put their drive and initiative to work! Position Location Clinical Research Associate Minneapolis, MN Salary Highly competitive package, commensurate with experience Responsibilities 1) Analyzes and evaluates clinical data and ensures compliance with protocol and overall clinical objectives. 2) Responsible for implementing, facilitating, and monitoring clinical trials at investigational sites. 3) Conducts on-site monitoring visits in accordance with Federal Regulations, Good Clinical Practices, ICH Guidelines and company Standard Operating Procedures. 4) Establish professional rapport and frequent communication with investigational site personnel and document with appropriate forms and monitoring reports. 5) Educate the investigational sites in all regulatory procedures, protocol interpretations, documentation requirements, and data clarification. 6) Ensure accurate documentation and completion of all follow up information on serious adverse events identified. 7) Understand, implement, facilitate and maintain project timelines and seek assistance from other team members when appropriate. 8) Proactively work to identify, address, resolve and communicate all ongoing investigational site issues in conjunction with the project team. 9) Demonstrate, understand and comply with company SOPs and ICH/GCP Standards. 10) Manage and monitor Initiation, Interim, and Closeout study visits. 11) Participate in the recruitment of sites. 12) Participate in the development of study related tools. Requirements 1) Requires a Bachelors/Masters degree in a scientific discipline or equivalent. 2) Knowledge of U.S. Drug Development process and monitoring practices; knowledge of FDA regulations/ICH strongly preferred. 3) Must have demonstrated knowledge of industry standards in managing clinical data for studies in pre-approval phases. 4) Minimum 2-5 years experience monitoring studies required. 5) Nursing License or ACRP or SOCRA certification preferred. 6) Ability to travel as required. 7) Excellent verbal, written, and presentation skills as well as computer proficiency.