Karius and Duke Demonstrate that the Karius Test Accurately Detects and Quantifies Microbial Cell-free DNA in Patients with Infective Endocarditis | Karius

Karius and Duke Demonstrate that the Karius Test Accurately Detects and Quantifies Microbial Cell-free DNA in Patients with Infective Endocarditis

October 03, 2018

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.

Karius is on a mission to help clinicians do more for their patients by bringing the genomic revolution to infectious disease diagnosis. The Senior Clinical Research Associate (Sr. CRA) reports to the Head of Clinical Affairs. We are looking for an experienced self-motivated, critical thinker that can work independently within a high performing clinical operations team. In this role, the Sr. CRA is responsible for the management of a portfolio of investigator initiated studies (IIS) program that apply Karius’ novel diagnostic technology across a broad range of clinical indications.

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;
· Lead contract development and budget negotiations for the IIS program
· Collaborate in study design from protocol development to the design of case report forms and statistical analysis plan
· 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 to support the IIS program
· 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 and the IIS program as a whole to internal and external   teams
· Support the development and submission of posters, abstracts, and manuscripts relevant to the IIS program portfolio
· 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 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%)