One Drop is seeking a Clinical Research Scientist with an opportunity to work full time remotely. The Clinical Research Scientist will lead device trial strategy and study designs to support regulatory approval as well as device and program evidence generation for stakeholders.
One Drop is the future of healthcare. Their mission is to develop technology that ensures all people living with diabetes and other chronic conditions can thrive. They harness the power of data science and mobile computing to make healthcare more affordable, accessible, and effective.
- Once in a lifetime chance to deeply impact the lives of people with chronic conditions
- The opportunity to contribute at an early stage startup and help develop the future of healthcare
- Competitive salary as well as equity commensurate with experience and performance
- Medical, Dental, and Vision insurance as well as 401k plan
- In addition, the Yearly Professional Development budget
- Moreover, unlimited vacation days
Duties and Responsibilities of Clinical Research Scientist
- Apply experience and expertise along with a team to the development of comprehensive pre-clinical and clinical trial strategies aimed at generating the evidence required for device development, regulatory approval in the US and internationally and maintaining regulatory approvals.
- Develop study designs, protocols and plans to support overarching clinical strategy, incorporating input from leadership, consultants and other experts.
- Also, develop requests for proposals and evaluate vendor proposals, researching feasibility and the research partner landscape
- Perform medical and scientific review of study plans, materials and deliverables created by CRO’s to ensure studies achieve regulatory and business goals.
- Provide scientific support for the site selection process and for site recruitment questionnaire development.
- Serve as the scientific point of contact providing scientific assistance and support for the study teams who oversee trials, providing clinical, therapeutic and scientific expertise to the study team
- Support the creation of trial deliverables and provide scientific support for the site selection process and for site recruitment questionnaire development.
- Perform medical and clinical research data review to ensure that the data is coherent, complete, and accurate and is suitable to meet study deliverables.
- Create data summaries as well as assist in the development and preparation of scientific manuscripts, abstracts, poster and oral presentations, and other meetings as required.
- Moreover, follow standard operating procedures, ICH-GCP, and all applicable regulatory requirements.
- Bachelor’s Degree (4-year program) required; PhD preferred
- Minimum 3 years of experience in clinical research and/or laboratory-based research
- Experience in endocrinology clinical research and/or endocrinology-focused laboratory-based research, with experience in an academic or community medical centre, or in the pharmaceutical, biotechnology, contract research industry or similar research entity.
- Familiarity with medical data review.
One Drop recognizes that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying.