Senior Clinical Research Associate | Karius

Senior Clinical Research Associate

Karius is a venture-backed life science startup focused on transforming the way infectious diseases are diagnosed.  Combining Next-Generation Sequencing and proprietary data analysis, we can identify over 1,000 pathogens from a single blood sample with typical turn around time in one business day. By introducing liquid biopsy into the diagnosis of infectious diseases, we're helping doctors quickly solve their most challenging cases, with a future vision of accelerating clinical trials, discovering new microbes, and reducing patient suffering worldwide.

We are looking for an experienced, self-motivated, critical thinker that can work independently within a high performing clinical operations team. You will enjoy a high degree of autonomy and independence as you manage your study program. In your role you will be making a meaningful difference by contributing to building the clinical evidence for a novel technology for patients with serious infectious diseases. As a key member of the team, you will work directly with the Head of Clinical Affairs and work in our office in Redwood Shores.
 
 
You Will:
·       Develop project-specific documents such as protocols, informed consents, monitoring plans, study budgets, and other study-related documents
·       Maintain complete and accurate clinical trial master files (TMF) for assigned studies at all times
·       Collaborate in study design from protocol development to the design of case report forms, statistical analysis plan and final analysis
·       Assist Medical Affairs team members as clinical operations subject matter expert in the evaluation of external research proposals submitted to Karius (e.g., logistics requirements, site suitability, protocol feasibility, proposed analyses)
·       Design and create study-specific specimen collection kits and protocols
·       Develop study-specific laboratory operational procedures
·       Lead the compilation, review, and reporting of Karius Test data to internal Medical Affairs team and to research collaborators
·       Serve as the lead for communications and interactions with clinical investigators and site personnel
·       Report study metrics for individual studies for your assigned program to internal and external teams
·       Support the development and submission of posters, abstracts, and manuscripts with opportunity to fulfill authorship requirements
·       Ensure proper adherence to clinical research regulations (i.e. GCP, ICH, and HIPAA)
·       Provide project management oversight and track status of clinical trial timelines and deliverables
·       Work closely with data management to develop case report forms and manage study data in electronic data capture systems
·       Manage clinical study sites with strong customer service orientation, manage site selection, subject recruitment, study payments, perform SQV, SIV, IMV (including remote monitoring) and COV when needed
·       Efficiently complete monitoring visit reports and follow-up tasks
·       Coordinate and participate in investigator meetings and other site training activities
 
You Bring:
·       BS or higher degree in science, nursing, or equivalent discipline
·       A minimum of 5 years of clinical research experience in biotechnology, pharmaceutical, or CRO industry with medical device and/or diagnostic development experience preferred with molecular diagnostic experience a plus
·       Specimen procurement and/or management experience preferred
·       Ability to thrive in a fast-paced start-up environment, prior start-up experience preferred
·       Strong, confident presentation and communication skills
·       Strong working knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials
·       Ability to perform multiple tasks, proactively plan, adhere to timelines, and have a creative approach to problem solving
·       Leadership and mentorship skills with a collegial approach to team building
·       Excellent organizational and self-management skills
·       Experience with managing studies in electronic data capture systems
·       Proficiency with Microsoft Word, Excel, PowerPoint, Project
·       Ability to travel (~20%)

Full-time
Redwood Shores