Vault Health is a digital healthcare company and a leading provider of at-home FDA-approved COVID testing in the United States. Our solution has been deployed to numerous local and state governments, airlines, universities, professional athletic teams, companies and organizations. To date, we've tested millions of people, providing accurate and timely information in the battle against COVID.
Founded in New York City in 2018, Vault Health specializes in Consumer Health, Population Health, and Clinical Trials. Our vision is to deliver seamless and modern healthcare experiences for diagnostics, treatment, and medical care - a digital experience that reduces the need for patients to have to set foot in a doctor’s office. Today, we need your help more than ever to battle the pandemic and build a next generation digital native healthcare company that will transform the world of healthcare.
Vault Health is seeking a Clinical Trials Study Start Up Lead who works to perform comprehensive study startup support. This person will be responsible for the expeditious coordination of the regulatory submissions in the study startup phase to support key metrics reported to institutional leadership. At any given time, there will be 15 - 20 trials actively in startup.
- Prepare and submit required internal and external submissions over the course of study startup and site activation. These include but are not limited to the submissions to an Institutional Review Board (central or local), the Institutional Biosafety Committee, the Radiation Safety Committee, and the Scientific Review Committee.
- Write informed consent forms in accordance with GCP and FDA guidelines, ensuring all appropriate elements of informed consent. Must be able to explain complicated research protocol requirements to research participants using easily understood language.
- Understand the timing and implications of other team members’ start-up requirements to ensure accurate and effectively timed submissions.
- Implement process improvements to mitigate risks to activation timelines
- Liaise with investigators, industry sponsors, and study teams to ensure accuracy of documentation
- Create tools to support organized startup efforts to be used within the team
- Oversee the execution of all start-up related activities through last site activated according to study strategy
- Exhibit sound decision-making skills, utilizing all available resources for determining positive outcomes.
- Create, manage, and supply supportive documents such as 1572s, financial disclosures, laboratory accreditations, laboratory reference ranges, CVs, medical licenses, delegation of authority logs, and required training documentation
- Integrate information from multiple sources and use specialized knowledge of institutional, state, and federal requirements to ensure compliance with those entities
- Create and manage detailed project schedules for clinical evaluation
- Follow up on (PMCF) plans and reports, and Summary of Safety and Clinical Performance (SSCP) documents
- Responsible for providing quality on deliverables and follow project requirements and applicable rules
- Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in tracking system in real time; if forecasted timelines are not reached provides clear rationale for delays, assists with contingency plan to mitigate impact, and escalates the issue as soon as identified.
- Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
- Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Vault SOP/Sponsor requirements.
- Be responsible for driving increased efficiencies yielding a decrease in site activation cycle times
- Analyze data and metrics relating to the site activation pathway
- Other duties as assigned
- Bachelor’s Degree in Clinical, Science, or Health-related field from an accredited institution or a licensed health-care professional
- Clinical research related certification preferred
- FDA, GCP, and NIH requirements relating to research involving human subjects
- Strong organizational and document management skills
- Strong and effective verbal and written communication skills
- Strong analytical and problem-solving skills
- Excellent time management skills
Vault is a high growth, fast paced organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically (and potentially internationally) is required, it is anticipated that this will be less than 15 % of work time.
Who You Are:
- Dynamic, gregarious individual with a constant focus on the patient experience
- Background in the life sciences / healthcare / clinical trials space with an understanding of the space
- High comfort level with ambiguity; adapting to change, learning, and growth
- Proactive, forward-looking, flexible and creative team player who enjoys collaborating and getting things done without an ego
- Open to receiving and giving feedback
- Highly effective written and verbal communication skills
- Organized, with a strong ability to multitask and shift priorities when needed
- Entrepreneurial approach to responsibilities
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.