Website hellodotlab DotLab
The future of women's healthcare, bringing you the first-ever test for #endometriosis
DotLab, a personalized medicine company focused on women’s health, is looking for an outstanding Clinical Research Associate to support the development of our cutting-edge molecular diagnostic test for endometriosis. Ten percent of women of child-bearing age suffer from this debilitating disease, which can take up to ten years to diagnose today. We’re looking to change that.
What you’ll be doing:
- Participate in the development of protocols, case report form and other critical study documents.
- Coordinate and manage DotLab clinical studies, including site qualification, training and monitoring, regulatory compliance and ongoing site management.
- Oversee the quality of both clinical data and clinical sample collection
- Develop and implement strategies for successful, on-time site and subject recruitment.
- Work across functions in the company to support the clinical development program and product development pipelineVerify accuracy of clinical data and ensure compliance with protocol and regulatory requirements.
- Manage key vendor relationships and study budgets.
- Develop critical relationships with investigators, KOLs and site personnel.
- Contribute to the development and maintenance of forecasting and performance metrics.
- Travel 50-75%.
What we’re looking for:
- Bachelor’s degree in biology or related field; master’s degree preferred.
- 2 or more years CRA experience in life sciences company; experience with diagnostics or device development preferred.
- Energetic and creative self-starter with experience in a small or startup environment.
- Able to develop and maintain strong relationships and has excellent communication skills; leads lead via influence.
- Able to flexibly pivot as needed to support clinical development needs and to bring sites and key stakeholders along when change is required.
- Proficiency in Microsoft Office, electronic data capture, clinical trial management systems.