About the Company
Talis aims to transform diagnostic testing by developing and commercializing innovative products that are designed to enable accurate, reliable, low cost and rapid molecular testing for infectious diseases and other conditions at the point-of-care. While timely diagnosis of infectious diseases is critically important to enable effective treatment, testing is primarily performed in centralized laboratories, which require samples to be shipped for processing, delaying the return of results by days. Point-of-care testing solves this problem by delivering the timely information necessary for clinical care.
We are developing the Talis One platform, a sample-to-answer, cloud-enabled molecular diagnostic platform that, once authorized, could be rapidly deployed to distributed diagnostic settings in the United States and around the world to diagnose infectious disease at the point-of-care. The Talis One platform comprises a compact instrument, single-use test cartridges and software, including a central cloud database, which work together and are designed to provide central laboratory levels of accuracy and be operated by an untrained user.
Talis has raised more than $500 million in the past twelve months, including a $254 million IPO. We are actively preparing for our initial product launch that tests for COVID-19 and a rapid commercial and operations scale-up.
As a R&D Acquisition Research Associate you will be responsible for acquisition of clinical samples to support the development of new Point of Care Diagnostics. You will be responsible for all aspects of vendor management according to project timelines and in compliance with ICH GCP, country regulations, and SOPs. This role will provide you with the opportunity to expand your knowledge and experience in New Product Development and Verification. This position is based at our Menlo Park, CA location and is not open to a remote hire.
Specific responsibilities include, but are not limited to:
- Lead clinical sample acquisition for R&D and Assay Verification activities under the guidance of the Assay Development Lead.
- Assists the Assay Development Lead with sample acquisition start-up activities including vendor selection.
- Leads the generation of study documents including, but not limited to, IRB protocols and amendments, informed consent forms, eligibility and demographic forms, study plans and tracking tools.
- Manage and organize internal team meetings, vendor meetings, and other sample collection meetings, as requested.
- Prepares and presents sample collection progress reports to Assay Development Team.
- Maintains oversight of R&D clinical sample acquisition activities and the overall vendor management ensuring compliance with project-specific plans, Good Clinical Practices (GCP) and applicable regulations.
- Timely issue escalation to Assay Development Lead and to assist with the resolution of issues.
- Responsible for R&D clinical sample intake, inventory tracking and reconciliation, storage location documentation and sample usage.
- Works with legal on vendor contract, budget, and payment process.
- Cultivate and maintain excellent working relationships with study vendors.
- Provide accurate and up-to-date information and study status reports to the Assay Development team members.
- Must demonstrate good judgment in selecting methods and techniques for obtaining solutions.
- Follows project timeline to meet deadlines for assigned tasks and communicates with Assay Development Lead with any updates or changes to the study timeline.
- Partners with team members and other functional areas including Assay Development, Regulatory, QA, Legal.
Required Education & Experience
- Bachelor’s degree with 2-3 years of relevant experience.
- Knowledge of clinical specimen collection, medical terminology, and ICH GCP guidelines.
- Clear and concise verbal and written communication skill, including English fluency, and strong organizational skills.
- Ability to multi-task, prioritize, track projects, and follow-through on-time with assigned tasks.
- Exceptional attention to detail.
- Ability to work independently and as part of a team.
- Proactive; applies critical thinking to improve execution of study tasks.
- Ability to learn quickly and effectively using newly acquired skills.
- Willing to embrace change and work in a changing environment.
- Able to work collaboratively across cultures and geographies.
- Proficiency in Microsoft Outlook, Word, PowerPoint, Excel.
Talis offers a comprehensive health and well-being benefits programs, long-term equity incentives, time-off policies, a 401(k) retirement savings plan with an immediate Company match, Education Assistance Program, a rotating suite of snacks, Monday breakfasts, Happy Hours, other fun company events and more! Best of all, join us by working at a growing company like Talis with dedicated and collaborative employees committed to making a difference in Health Care.
Talis is proud to be an equal opportunity workplace. All aspects of employment decisions will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of any status protected under federal, state, or local law. We celebrate diversity and are committed to creating an inclusive environment for our colleagues.