Sr. CRA/Site Manager w/Med Device Experience in Plymouth, Minnesota

Kelly Clinical Research has a direct hire Senior Clinical Research Associate opportunity with a medical device company located in Plymouth, Minnesota. Position comes with excellent benefits and bonus opportunities!Responsibilities include:Schedule and conduct monitoring activities at assigned centers assessing site compliance to the clinical investigation plan, regulations and GCPs, as needed. Obtain all relevant source data for adverse events and deaths, as needed. Assist in the writing of AE/Death Summaries. Follow-up with any adverse event issues identified by the medical advisor. Develop and implement independently corrective and preventive actions at sites and provide continuous compliance and oversight. Initiate the creation of specified contracts, negotiating finalized agreements, proactively initiating amendments. Strategically planning site and study financial matters. Conduct study training or other formal training at site and at the study team level. Develop informed consents, ensuring the contents contain all required elements. Conduct in-house case report form auditing and data verification. Responsible for data review and approval of DCFs; understanding of the interactions between forms and can propose solutions to questions regarding form completion. Manage assigned clinical study centers. Participate as a speaker at study functions, as needed. Assist in the creation of study related materials, such as: subject brochures, subject recruitment materials, trial guide and physician referral presentations. Work independently on specific study projects. Acquire professional, product and market expertise via independent reading, networking and training. Resource/train other clinical study team members. Travel approximately 20-30% (as project needs require). Participate in professional activities outside of normal business hours. Qualifications:BA/BS in Medical Science, Nursing or related area. 3-5 years experience in clinical research, preferably with a medical device company. Knowledge of clinical research study processes and study design; ability to incorporate and adhere to Good Clinical Practices, regulatory standards and follow department Standard Operating Procedures. Computer proficiency required: Word, Excel, Access, PowerPoint, internet, email. Ability to critique and analyze data in reports and identification of potential trends. Capable of producing professional correspondence, presentations, reports and training materials. Problem solving capabilities - proactively identification of issues, proposing solutions, understanding root cause and making recommendations to study team.Ability to constructively interact with a range of personalities and positions both inside and outside of the organization. Attention to detail. Ability to organize, prioritizes, and manages tasks in a changing environment. Ability to work independently, seeks assistance when needed and take direction from others. ** Applicants must be able to show proof of eligibility to work for any employer in the US without restriction. **If you meet the above qualifications and would like to be considered for this opportunity, please Apply Now! Or you may refer a friend by clicking 'Email this opportunity to a friend'. Learn more about company