Wright Medical Group N.V. Clinical Research Coordinator - Minneapolis MN in Minneapolis, Minnesota
Job Title: Clinical Research Coordinator - Minneapolis MN Job Description: The CRA will work with the Clinical Manager to satisfy applicable regulatory standards and internal requirements for worldwide post market and US IDE clinical studies. Bridges the responsibilities of the Clinical Study Coordinator and the Clinical Study Manager and focuses on study management activities, monitoring, oversight of Clinical Sites and CRO's, etc. Responsibilities: Contributes to Clinical Research team activities for designated projects and to ensures patient safety, quality and integrity of data, compliance with relevant SOPs and regulatory requirements, and completes studies on-time and on-budget Assists with successful conduct of assigned studies consistent with R&D and Marketing plans. This includes interfacing with representatives from key functional groups including Product Development, Manufacturing, Sales, Marketing, Distribution, and Regulatory Affairs. Assists in physician training, trains site research coordinators, develops study guides and SOPs, resolves queries, assists investigational sites with ethics committee submissions, attends team meetings, and works with CROs. Coordinates and participates in physicians meetings such as Investigator Meetings and Adverse Events Committees. Authors the monitoring plan, coordinates and conducts site initiation, interim, and close-out visit monitoring at participating centers to ensure compliance with the protocol and regulations and the timely receipt of accurate data and other required study documents. Reviews clinical data/information and oversees data correction. Assists study managers in providing interim and final reports and presentations. Provides input to study budgets and project plans. Assists study manager in preparation of clinical protocols, reports, and FDA submissions. Manages clinical sites during the site activation process and through the lifetime of the study. Takes initiative to oversee assigned clinical research activities. Requirements: Bachelor's degree (technical or non-technical) Technical degree defined as engineering, biological sciences or related medical/scientific field required At least 1 year of experience in clinical research as a CRA (or similar role) 3+ years' experience in related industry Sponsor experience preferred Knowledge of clinical and outcomes research study design. Up to 60% travel Compliance: Every employee is responsible for adhering to the AdvaMed Code of Ethics on Interactions with Health Care Professionals and any related ethical, compliant business practices, including, but not limited to, compliance with the Company's Compliance Program, FDA regulations and guidance, Anti-Kickback Statute, and other Federal, state and/or local laws. Every employee is responsible to complete required compliance training successfully and on-time. This job description in no way states or implies that these are the only duties to be performed by the employee in this position. Employee will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. Tornier is an Equal Opportunity/ Affirmative Action employer. We provide equal employment opportunities to all qualified employees and applicants for employment without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, veteran status, disability or any other legally protected status. We prohibit discrimination in decisions concerning recruitment, hiring, compensation, benefits, training, termination, promotions, or any other condition of employment or career development.