Clinical Research Scientist
RIVANNA is seeking an experienced 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 managing complex clinical research programs in partnership with federal agency sponsors. 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.
The Clinical Research Scientist is responsible for the overall management and oversight of future contracted clinical trials, including (but not limited to) development of project documentation, monitoring study progress to assess protocol adherence, administration and oversight of study budgets, management of third-party vendors for clinical services and/or contract CRAs, as applicable, management of project timelines, and development of project deliverables.
- Responsible for pre-clinical development activities such as market research, healthcare economics and pilot study management
- Responsible for early pilot studies and clinical trial planning and execution
- Serves as a liaison between clinical sites/CROs and internal team to ensure project specific information and ongoing updates are proactively communicated
- Responsible for development of clinical study protocols and consent documents for ethics/IRB approval, and other trial related materials as required
- 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
- Prepare and edit manuscripts, abstract and posters
- Create project plans, protocols, amendments, quantitative analyses, and reports
- Establish relationships with investigators and KOLs and maintain engagement with KOLs and stakeholders
- Responsible for clinical subcontract management
- Proactively track and manage clinical project 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.
Experience and Qualifications
- Master’s degree in engineering, science, or related field with PhD preferred
- Minimum 3 years of experience in clinical research and/or laboratory-based research, with experience in an academic or community medical center, or in the pharmaceutical, biotechnology, contract research (CRO) industry or similar research entity preferred
- Experience with medical device technology and clinical trials desired
- Experience in research writing, data mining, literature searches, and quantitative and qualitative analyses
- Excellent communication skills and expertise with project management tools
- Health insurance
- Paid time off
- Team/family events
- and more.