Senior Clinical Research Associate | Karius

Senior Clinical Research Associate

About Karius
Karius is a venture-backed life science startup that is transforming the way pathogens and other microbes are observed throughout the body.  By unlocking the information present in microbial cell-free DNA, we're helping doctors quickly solve their most challenging cases, providing industry partners with access to 1000’s of biomarkers to accelerate clinical trials, discovering new microbes, and reducing patient suffering worldwide.

Why Should You Join?
Karius aims to conquer infectious diseases through innovations around genomic sequencing and machine learning. The company’s platform is already delivering unprecedented insights into the microbial landscape, providing clinicians with a comprehensive test capable of identifying more than a thousand pathogens directly from blood, and helping industry accelerate the development of therapeutic solutions. The Karius test we provide today is one of the most advanced solutions available to physicians who aim to deliver better care to many otherwise ineffectively treated patients. Our test is the result of some incredible work done by our scientists, statisticians, engineers, and physicians, all driven by the same mission. You, as part of the Karius team, will be able to see how directly your work has a life-changing impact on people, and at scale.

Position Summary
The Senior Clinical Research Associate is responsible for oversight and monitoring activities that will lead to the successful execution of clinical studies. They will prepare, leads and execute clinical operations study tasks, including documents (may include plan, protocol, report); initiation, monitoring, and completion of clinical studies for verification and/or validation. 

Reports to: Director, Clinical Operations

Location: Redwood City, CA

Responsibilities
- Manage clinical study sites with strong customer service orientation, manage site selection, subject recruitment, study payments, monitoring and closeout visits.
- Provides or leads project-specific clinical study support; develop project-specific documents, protocols, informed consents, monitoring plans, study budgets, and other study-related documents.
- Proactively identify and resolve clinical project issues and participate in process improvement initiatives, as applicable.
- Engage with study investigators, vendors and internal/external stakeholders.
- Critically review on-site files and source documents for completeness, accuracy, and compliance; identify deficiencies and discrepancies and provide effective remedial training/corrective action as required.
- Establish and manage clinical trial master files (TMF).
- Assist in developing clinical trial timelines and effectively demonstrate adherence to deliverables. 
- Work closely with Clinical Data Management to develop case report forms and manage study data in electronic data capture systems. Effectively manage query resolution.
- Coordinate and participate in investigator meetings and other site training activities.
- Prepare internal and external project updates for management.
- Participate or lead study team meetings and collaborate with other functional groups within the company to achieve clinical study goals and timelines.
- Ensure proper adherence to clinical research regulations, such as GCP, ICH, and HIPAA.
- Complete all assigned and required training satisfactorily and on time.
- Perform tasks such as inventory, shipping and other tasks as needed. 

Travel:  30% to 50%

Physical Requirements
- Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office environment.

Position Requirements
- BS or higher degree in science, nursing (RN or BSN), or equivalent discipline.
- A minimum of 4 years of clinical research experience in biotechnology, pharmaceutical, or CRO industry.
- Strong working knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trials.
- Experience with managing studies in electronic data capture systems.
- Experience with project, vendor, contract, and clinical research staff management.
- Experience with Institutional Review Board (IRB) preparations and submission.
- Ability to work independently, collaboratively and manage deadlines.
- Experience with reviewing electronic medical records.
- Knowledge in molecular diagnostics or laboratory skills is a plus.
- Proficiency with Microsoft Word, Excel, PowerPoint and Project.

Personal Qualifications
- Good understanding of medical terminology and laboratory testing.
- Excellent communication and interpersonal skills.
- Ability to thrive in a fast-paced startup environment and prioritize effectively.
- Strong, confident presentation and communication skills.
- Must have strong initiative and be a self-motivator.
- Detail oriented with excellent organizational and self-management skills.
- Ability to perform multiple tasks, proactively plan, adhere to timelines, and have a creative approach to problem solving.
- Has curiosity and is passionate about having an impact on patient’s lives.

At Karius, we value a diverse and inclusive workplace and provide equal employment opportunity for all applicants and employees and are committed to honor and invest in the full diversity of people, in our hiring, recruiting and development of employees across the Company.  All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at recruiting@kariusdx.com and we will accommodate qualified individuals with disabilities.

Full-time
Redwood City, CA