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SalaryRIVANNA is seeking a talented Clinical Research Associate to contribute to the rapid growth of our emerging medical device company. You will work with a talented team of professionals as we strive to achieve our mission of improving global human health. The ideal candidate has prior successful experience in biomedical and/or Clinical Research. This is a hands-on, multidisciplinary role in which the right candidate will work closely with engineering, regulatory, and manufacturing programs to get our breakthrough medical technologies to direct clinical and preclinical studies.
Responsibilities
- Assist with the coordination of all clinical program activities, including technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and direction of all clinical activities.
- Assist with tracking and management of clinical tasks.
- Assist with the preparation of clinical project status and progress reports.
- Coordinate communication and clinical project activities within the department, to sites, and stakeholders.
- Assist with training site staff in preparation for study launch.
- Assist with continual and periodic monitoring of site/study data.
- Engage with internal commercial, research and development, and manufacturing teams to ensure successful planning, coordination, and execution of Clinical Research work packages.
- Assist with the completion of clinical-related content including informed consent forms, case report forms, and clinical study reports.
- Participate in preparing and reviewing study documentation.
- Irregular travel for conferences or to visit clinical sites is anticipated.
- Develop and implement data management and quality control systems/procedures, including transmission, storage, confidentiality, and retrieval of all program data.
- Assist with clinical statistical analysis efforts.
Skills and Qualifications
- Master’s degree in science, public health, or related field.
- Minimum 3 years of experience in Clinical Research preferred.
- Experience with medical device technology and clinical studies or trials.
- Understanding of FDA medical device regulations preferred.
- Strong communication skills, both verbally and written.
- Data analysis skills.
Demonstrated ability to set and meet tight deadlines and function well under pressure.
RIVANNA Medical offers the following employee benefits: health insurance, vision and dental, group life, long-term disability, paid time off, 401(k) with match, and more. We are always looking to complement our existing team with individuals who bring unique perspectives and experiences. This variety of thought and perspective drives innovation and strengthens our ability to create an inclusive team environment where our core values of trust, humility, and dedication are practiced every day.
RIVANNA Medical is committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breastfeeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability or any other protected status in accordance with all applicable federal, state and local laws. All employees must be able to lift at least 25 pounds. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.
About the Company
RIVANNA® is a privately held designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA. RIVANNA operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro® product line and related medical equipment and components. Accuro is the world’s ?rst spinal navigation device designed to improve the safety, speed and efficiency of spinal needle guidance procedures. RIVANNA’s revolutionary platforms feature BoneEnhance®, Multi-Frequency Image Reconstruction, which optimizes ultrasound for the visualization of bony versus soft tissue anatomy, and SpineNav3D™ AI-Based Spine Recognition, which automates ultrasound image interpretation.
