Vault Health is a health technology company that provides medical services and tech platforms for hybrid clinical research, large-scale public and enterprise diagnostic testing, at-home clinical care, and employment screening. The company builds scalable technology which enables drug manufacturers and trial sponsors to bring new therapies to market faster through efficient decentralized clinical research and seamless integration across partners. Vault’s 50-state medical practice covers more than 20 therapeutic areas and provides clinical expertise to Vault’s clinical research, diagnostic testing, and clinical care businesses. Vault was founded in 2019 and is based in Miami, Florida.
About the Role:
The Principal Investigator manages and oversees clinical research studies and has first-hand knowledge and expertise in the design and conduct of clinical trials, with an emphasis on decentralized and hybrid clinical trials. The PI uses his/her clinical, scientific, and operational knowledge to contribute to the development of innovative trials, improve safety, and advance scientific knowledge. The PI drives clinical oversight and quality of the studies virtually across a site network and ensures the medical well-being and safety of the study participants through the safe performance and execution of each clinical trial. This is a completely remote role within the US
What You will do:
- Maintains oversight and responsibility for all aspects of assigned clinical studies
- Ensures the medical well-being and safety of the study participants through the safe performance and execution of the clinical trials/studies
- Evaluates potential participants for inclusion and exclusion study criteria including the review of medical history, con meds and other criteria to ensure compliance with study protocol.
- Performs informed consent discussions
- Reviews all adverse and serious adverse events
- Reviews laboratory results
- Serves as Scientific Advisor and provides guidance to Project Managers on the medical and scientific aspects of assigned trials
- Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility
- Performs medical review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs)
- Provides therapeutic area/indication training for the project clinical team
- Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
- Maintains awareness of industry development
What Qualifications you will need:
- Able to commit at least 8 hours/week to investigator activities
- Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medicine education
- Valid registration as a medical practitioner, with a medical license in good standing and with unrestricted ability to practice
- Minimum 5 years experience in clinical medicine in addition to 2 years clinical trials experience as an investigator in the specified therapeutic area
- Specialty board certification preferred
- Understands regulatory requirements, as well as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Thorough understanding of the drug development process
- Candidates who are fully vaccinated or willing to take the COVID-19 vaccination are encouraged to apply. Proof of vaccination will be required to start working
- Entrepreneurial mindset
Vault Health is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, national origin, age, disability, or veteran status.