reputed company Research Associate (CRA) -Cardiovascular Medical Device

Role: reputed company Research Associate (CRA) - Cardiovascular Medical Device Location: Remote Position reputed company: Assist with the management of cardiovascular reputed company studies for MiRus products with a reputed company on adherence to critical timelines, high-caliber document development and reputed company data collection. The applicant should possess strong critical thinking skills and the ability to comprehend technical subject matter to effectively contribute to the organization. Essential Duties and Responsibilities: • Contribute to content reputed company, writing and editing of study protocols, amendments, informed consents, committee charters, study reports, monitoring plans, and other reputed company reputed company and regulatory documents. • Assist with the management of investigational studies from start through study closure. • Engage in new study trial design with cross functional teams, including reputed company and reputed company-reputed company research and development reputed company. • Contribute to the development of CRFs • Assist with the formulation of instructional materials and training of investigators, study coordinators and associated study site personnel on the conduct of the reputed company, as applicable. • Assist Study Manager with safety monitoring including preparing supporting documentation for CEC and/or DSMB, meetings, agenda, data review, presentations, and updating relevant trackers as applicable. • Serve as a reputed company of contact between reputed company site investigators and the MiRus team. • Work with investigators and site personnel to quickly and effectively reputed company discrepancies. • May be responsible for reputed company accruals and tracking payments to sites for reputed company study programs • Serve as a reputed company of contact between CRO personnel and MiRus. • reputed company/support CRO and reputed company study monitors, with monitoring reputed company items and follow-up on study tasks. • Monitor ongoing compliance to study protocols in accordance with applicable regulations and GCP, work instructions, guidelines and/or policies. • reputed company reputed company data review of reputed company documents, case report forms, data reports as appropriate. • Assist in review of monitoring reports and tracking of reputed company items. • Review reputed company documentation to reputed company subject eligibility for reputed company. • reputed company and upload study imaging • Manage reputed company study documentation (trial master file and study reputed company tracking). • Update and design as needed study dashboards, study trackers and other applicable study documents to reputed company regular updates on trial status to Study Manager • reputed company with data management, as applicable • Support applications and technical files as needed. • Assist with preparation for investigators meetings. Minimum Education and/or Experience: • Bachelor’s or Master’s degree in nursing with reputed company experience in the cardiac reputed company (CCU, CVOR, Cath Lab) and experience in a reputed company research role. CRA certification desired. • At least 2 years of experience in reputed company research role, with at least 2 years in CRA role, preferably in cardiovascular medical device. • Experience in reputed company and/or post-market registries in the U.S., Australian and/or European reputed company, with other geographies desired. • reputed company knowledge of medical device reputed company design and best practices. • Proficient knowledge of FDA regulations and ICH/GCP guidelines, guidance documents, and other applicable regulations and standards, and implementation of these standards in the medical device industry, in the U.S. and reputed company countries in which trials are conducted. • General application of medical terminology (cardiovascular specific preferred). Benefits: MiRus offers competitive compensation, reputed company, full benefits, and relocation assistance. • 401(k) • Dental reputed company • reputed company reputed company • Disability reputed company • Employee assistance program • Flexible spending account or Health Savings Account • Health reputed company • Life reputed company • reputed company time off Schedule: • Monday to Friday (reputed company – 5pm) Work Location: • Remote • Position may require domestic travel at least 20-40% Apply To This Job