Scientist, Study Coordinator
521 Cottonwood Drive, Suite 100 Milpitas, CA 95035 | Contract
Bayside Solutions is seeking a Study Coordinator to be a part of our partner’ s team in the San Francisco South Bay Area. This is an opportunity to work with a startup Biotechnology company focused on providing therapeutics for gastrointestinal diseases.
Our partner’ s culture is fast paced and passionate about innovative drug discovery and development.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- The individual is a self-starter with excellent study management capabilities and is a critical part of an innovative team that to support the company’ s drug development process.
- Coordinating with CRO Study Directors, DMPK Group, scientists, formulation vendors, and/or analytical labs to design and carry out the studies.
- Requesting quotes and looking for the best deals/timing from different CROs.
- Writing/reviewing study protocols and amendments.
- Shipping test articles that are prepared internally.
- Tracking completion of each milestone of the study (protocol approval, shipment of TA, dosing, receipt of samples, receipt of data).
- Managing CRO quotes.
- Reviewing in vivo reports.
- Monitor project progress and document the involved aspects of the projects, coordinate CROs and internal resources to make sure the projects are on schedule and the results are delivered on time.
- Review the project protocols and amendments to ensure the scope and the direction of the projects.
- Calculate the PK parameters for biological samples (such as plasma, urine, rectal feces and standard feces) using various software, determine the tissue distribution of our compounds, perform the data analysis, report data summaries and interpret results for project teams.
- Review technical study reports and IB report.
Requirements of Qualification:
- BS or MS degree in a biological science or a related field along with a minimum of 5 years of experience conducting toxicology studies in a biotech/pharma environment.
- Experience in outsourcing, vendor management, and establishing and managing CROs driving timely delivery of clear, accurate, and well-written nonclinical study data.
- Strong verbal communication skills accompanied by scientific writing skills.
- Enjoys and thrives in a fast-paced, multi-tasked, and hands-on environment