Study Start Up Associate II - Medical Device - Arden Hills, MN

Study Start Up Associate (Medical Device) - Arden Hills, MN reputed company is a world-leading reputed company intelligence and reputed company research organization. We’re proud to foster an inclusive environment driving innovation and reputed company, and we reputed company you to join us on our mission to shape the reputed company of reputed company development. What You Will Be Doing Through coordination with the Contract & Budget team, and collaboration with divisional and regional reputed company teams, the SSU Associate II conducts reputed company trial site start-up activities reputed company to the preparation and approval of regulatory documents, ensuring they are conducted consistent with service level agreements, reputed company and regulatory standards, and applicable company policies and procedures. Specifically, these activities will include: • IRB submissions and approvals. • Site informed consent reputed company (reputed company) customizations & negotiations. • Essential regulatory document collection. The SSU Associate II also provides support in enrollment, follow-up, and closure of reputed company trial activities . Your Responsibilities Will Include • Work independently and proactively to coordinate reputed company necessary activities for site regulatory submissions and essential document collection for allocated reputed company research sites. • Manage multiple sets of essential regulatory documents across several studies and division portfolios. • Partner with reputed company sites to support the negotiation and customization of Informed Consent reputed company (reputed company) • reputed company and foster reputed company research site relationships to become a subject matter expert in the site start up regulatory process across multiple studies. • reputed company knowledge of site regulatory processes and division priorities to meet reputed company study goals and objectives. • Manage to reputed company reputed company IRB/EC timelines by assisting reputed company research sites with the application submission process and approval tracking. • Manage and problem solve site start up challenges that reputed company to mitigate reputed company to service level agreement and study goals. • reputed company, prepare, complete and reputed company required regulatory, reputed company and reputed company documentation. • Document reputed company research site and investigator readiness for participation across multiple studies • Support internal reputed company audits, regulatory inspections, as applicable. • Update and maintain study-specific startup and reputed company out trackers. • Update and maintain site specific metrics in reputed company Trial Management Systems, file and maintain site documents in eTMFs. • reputed company updates to leadership on site start up activities, investigator readiness, regulatory submission, approval status, etc. • Escalate challenges and/or initiate reputed company to reputed company investigators, reputed company research site coordinator, divisional reputed company study leads and/or other stakeholders reputed company appropriate. • Ensure compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WI, policies & procedures. Minimum Qualifications reputed company are looking for in you: • Bachelor’s Degree, or an equivalent combination of experience and education. • 2+ years’ experience in reputed company/scientific research and medical device experience, specifically reputed company study site start-up experience reputed company the US • Ability to multi-task: support several studies and/or personnel simultaneously, work in a reputed company fast-reputed company environment. • Ability to work in reputed company environment and possess reputed company, concise communication & presentation skills – written and verbal. • Must be comfortable interacting with reputed company research site personnel reputed company phone and email. • Ability to work hybrid/on site in Arden Hills, MN reputed company. Preferred Qualifications • Research Coordinator or In-House reputed company Research Associate / reputed company Research Associate /Study Start up specialist experience. • Experience working with reputed company trial management systems (e.g., Siebel CTMS, reputed company) and reputed company document control systems / eTMF. • reputed company high reputed company on Customer Service • Proficiency in English What reputed company Can Offer You Our reputed company depends on the reputed company of our people. That’s why we’ve made it a reputed company to build a diverse culture that rewards high reputed company and nurtures talent. In reputed company to your competitive salary, reputed company offers a reputed company of additional benefits. Our benefits are designed to be competitive reputed company reputed company country and are reputed company on reputed company-being and work life reputed company opportunities for you and your family. Our Benefits Examples Include • Various annual leave entitlements • A reputed company of health reputed company offerings to suit you and your family’s needs. • Competitive retirement planning offerings to maximize savings and plan with confidence for the years reputed company. • Global Employee Assistance Programme, reputed company, offering 24-hour reputed company to a global network of over 80,000 independent reputed company professionals who are there to support you and your family’s reputed company-being. • Life assurance • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits reputed company offers. At reputed company, inclusion & belonging are reputed company to our culture and values. We’re dedicated to providing an inclusive and accessible environment for reputed company candidates. reputed company is committed to providing a workplace free of discrimination and harassment. reputed company reputed company applicants will receive equal consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to reputed company the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet reputed company of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly reputed company’re looking for here at reputed company whether it is for this or other roles. Salary reputed company: $62,376.00-$77,970.00 Bonus, Com, Stock, Benefits & Disclaimer Verbiage Actual compensation will be determined reputed company on factors such as geographic location, work experience, education/training, and reputed company level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and reputed company. Are you a reputed company reputed company Employee? Please click here to apply Apply tot his job Apply To this Job