RIVANNA is seeking a talented Clinical Research Scientist to contribute to the rapid growth of our emerging medical device company. You will work within 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 with a lead-author publication track record and grant writing experience.
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 as well as identify and submit for new funding opportunities. Individuals with various levels of experience are welcome to apply.
Key Responsibilities
- Responsible for scientific writing as related to Federal reporting, grant or contract proposals, and/or scientific publications.
- Engage with internal commercial, research and development, and manufacturing teams to ensure successful planning, coordination, and execution of clinical research work packages.
- Create and execute Federal funding strategies as related to new funding sources that advance the company’s technologies.
- Responsible for development of clinical evidence generation plans and execution.
- Perform medical and scientific review of clinical related content including scientific literature, clinical study protocols, informed consent forms, investigator brochures, case report forms, clinical study reports.
- Participate in preparing and reviewing study documentation, competitive landscape research and feasibility studies for new proposals as required
- Oversee and track progress of site identification, start-up, monitoring, and study close-out activities, including managing third-party vendors and / or contract CROs
- Establish relationships with investigators and KOLs and maintain engagement with KOLs and stakeholders.
- Proactively track and manage clinical development tasks against timelines and budgets.
- Prepare clinical project status and progress reports, maintaining accurate and current details for communication to internal and potentially external stakeholders.
- Irregular travel for conferences or to visit clinical sites is anticipated.
Experience and Qualifications
- PhD degree in science, or related field with medical ultrasound background preferred
- Established academic publication record, with successful grant writing experience preferred
- Experience in clinical research and/or laboratory-based research
- Experience with medical device technology and clinical studies or trials
- Understanding of FDA medical device regulations and medical device reimbursement
- Excellent scientific communication skills, both verbally and written
- Strong scientific rigor and data analysis skills
- Demonstrated ability to set and meet tight deadlines and function well under pressure
- Strong leadership and interpersonal skills with ability to effectively engage external stakeholders and build lasting relationships
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