Zymo Research is a private biotech company striving to have a positive impact in the biomedical field and to contribute to the greater good of humanity. The company’s strong R&D programs continue to drive innovation in the biotech and diagnostic fields and provide top quality products and services to its customers.
In the past couple of years, Zymo has been working on the development of diagnostics assays with a particular focus in the fields of oncology and infectious disease. Our immediate goal is to have an impact in the biomedical field by applying our technology and our deep understanding of genetics, epigenetics, and microbiology. A couple of these assays are already adopted by certified clinical laboratories. However, extensive and articulated clinical works (e.g., clinical studies in close collaboration with clinical centers) are in need to prove clinical utilities.
We are looking for a highly motivated and skilled individual with experience in conducting clinical studies that can help us to translate science in the clinical field.
- Assist during the discussion meetings focused on the goal and design of the clinical studies (study feasibility assessment, study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections, etc..).
- Coordinate clinical studies between Zymo and clinical centers, including preparing and providing protocol compliance, informed consents, review/approve IRBs, keep record and maintaining integrity of the data and results.
- Prepare study materials including, but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
- Maintains adequate inventory of study supplies.
- Keep communication and follow-up internally (with the clinical research, regulatory, and accounting teams) and with the clinical center's personnel.
- Manage the day-to-day activities of the study including problem solving, communication and protocol management.
- Engage with key opinion leaders.
- If applicable, help with the submission to regulatory authorities (FDA, etc..).
- Develop and maintain regulatory documentation files and documents; retain and store securely study records.
- Collaborate internally to prepare a categorized budget and justification.
- Acting as a liaison for research subjects, investigator, IRB, sponsor, healthcare professional.
- Take appropriate steps to avoid conflicts of interest.
This job position offers career growth. Zymo currently does not have a team dedicated to the design and execution of clinical studies. This position offers the possibility to form your own team within Zymo specialized in conducting clinical studies.