Clinical Research Associate (CRA) – Cardiovascular Medical Device

Posted 11 months ago Clinical Research Associate (CRA) – Cardiovascular Medical Device MiRus is an innovative healthcare company with a growing portfolio of cardiovascular and orthopedic products and deep proprietary technology in both implants and procedural solutions. MiRus was started by a team of experienced entrepreneurs with a history of creating disruptive technologies and very successful, highly valued companies. Job Summary We offer competitive compensation, options, and full benefits. Assist with the management of cardiovascular clinical studies for MiRus products with a focus on adherence to critical timelines, high-caliber document development and quality data collection. The applicant should possess strong critical thinking skills and the ability to comprehend technical subject matter to effectively contribute to the organization. Responsibilities Contribute to content generation, writing and editing of study protocols, amendments, informed consents, committee charters, study reports, monitoring plans, and other related clinical 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 clinical and pre-clinical research and development groups. ♦ 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 clinical trials, 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 point of contact between clinical site investigators and the MiRus team. ♦ Work with investigators and site personnel to quickly and effectively resolve discrepancies. ♦ May be responsible for patient accruals and tracking payments to sites for clinical study programs. ♦ Monitor ongoing compliance to study protocols in accordance with applicable regulations and GCP, work instructions, guidelines and/or policies. ♦ Provide continuous data review of source documents, case report forms, data reports as appropriate. ♦ Tracking of action items. ♦ Review source documentation to confirm subject eligibility for clinical trials. ♦ Track and upload study imaging. ♦ Manage clinical study documentation (trial master file and study related tracking). ♦ Update and design as needed study dashboards, study trackers and other applicable study documents to provide regular updates on trial status to Study Manager. ♦ Interact with data management, as applicable. ♦ Support applications and technical files as needed. ♦ Assist with preparation for investigators meetings. Requirements ♦ Bachelor’s or Master’s degree (in nursing with clinical experience in the cardiac field -CCU, CVOR, Cath Lab-preferred) and experience in a clinical research role. CRA certification desired. ♦ At least 2 years of experience in clinical research associate/monitoring role, preferably in cardiovascular medical device. ♦ Experience in clinical trials and/or post-market registries in the U.S., Australian and/or European Union, with other geographies desired. ♦ Current knowledge of medical device clinical trials 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 all countries in which trials are conducted. ♦ General application of medical terminology (cardiovascular specific preferred). Benefits MiRus offers competitive compensation, options, full benefits, and relocation assistance. ♦ 401(k) ♦ Dental insurance ♦ Vision insurance ♦ Disability insurance ♦ Employee assistance program ♦ Flexible spending account or Health Savings Account ♦ Health insurance ♦ Life insurance ♦ Paid time off Schedule ♦ Monday to Friday (8am – 5pm) Work Location: ♦ Remote ♦ Position may require domestic travel at least 20-40% Interested ? Please complete the contact information below and submit your resume to [email protected] Apply For This Job Name* Email* A valid email address is required. 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Assist in managing cardiovascular clinical studies by developing study protocols, monitoring plans, and ensuring high-quality data collection. Serve as the primary point of contact between clinical site investigators and the internal team while ensuring compliance with GCP and FDA regulations.

Requires a Bachelor's or Master's degree with at least 2 years of experience as a Clinical Research Associate, preferably in cardiovascular medical devices. Proficiency in FDA regulations, ICH/GCP guidelines, and experience with US, Australian, or EU clinical trials is required.

• 401(k) • Dental insurance • Vision insurance • Disability insurance • Employee assistance program • Flexible spending account • Health savings account • Health insurance • Life insurance • Paid time off • Relocation assistance • Stock options

Identified from the job description. Confirm important requirements above.

• Clinical Trial Management
• GCP Guidelines
• FDA Regulations
• Medical Device Monitoring
• Protocol Writing
• Case Report Forms
• Data Review
• Patient Accrual Tracking
• Trial Master File Management
• Cardiovascular Medical Terminology
• Clinical Research Monitoring
• Regulatory Documentation

• Science & Research
• Healthcare
• Engineering

Minimum education

Bachelor’s degree

Minimum experience

2+ years

Apply by

Sep 6, 2026

Posting language

English

Working hours

40 hours per week

Seniority

Entry level