Are you a problem-solver? A collaborator? Ready to tackle the world of infectious diseases? InBios is looking for people who value a sense of community, cooperation, and camaraderie with a shared vision of delivering impactful solutions to those affected by infectious diseases. At InBios, your ideas are valued, your voice is heard, your accomplishments are celebrated.

ABOUT INBIOS

InBios International Inc. specializes in the design, development, and manufacture of diagnostic assays for emerging infectious diseases and biothreats. Founded in 1996 in Seattle, WA, InBios is dedicated to delivering superior quality products that are accurate, easy to use and cost effective. We have a portfolio of more than 25 diagnostic products, as well as an extensive catalog of life science reagents. For more information, visit www.inbios.com.

Our primary location is in the dynamic neighborhood of South Lake Union in a state-of-the-art biotech facility, and our secondary location is in the SODO neighborhood with newly remodeled lab and office space in an historic building next to Lumen Field. InBios offers competitive wages and a rich benefit package that includes medical, dental and vision insurance, 401(k), and performance-based rewards. InBios is committed to work/life balance and provides paid vacation and sick time, including a weeklong, paid shutdown in December.

ABOUT YOU

We are seeking a detail-oriented and diligent individual with experience in data coordination. A data coordinator/clinical data coordinator will manage and organize study documents and data gathered from various clinical research studies and programs. The data coordinator/clinical data coordinator will be in charge of coordinating with different departments, maintaining study documents and databases with accurate information, identifying errors and inconsistencies, and maintaining records of all transactions. The data coordinator/clinical data coordinator will have a working knowledge of summary statistics, SQL, Oracle views, Python (or R, JMP, GraphPad, etc.) and willing to incorporate their skillset in a high-paced environment.

Job duties will include:

• Assisting with the development and maintenance of study documentation (preparation of protocol, consent forms, data management plan, statistical plans, source documents)
• Collaborating with study teams to ensure data is collected and reported accurately 
• Designing eCRFs for data collection and study databases
• Maintaining and monitoring study data collection databases
• Managing participant data throughout studies, and perform quality control checks 
• Reviewing and validating collected data; performing data cleaning and quality control activities
• Collaborating with study teams to ensure data is entered into the database in a timely and accurate manner 
• Generating regular data listings and data reports or as needed 
• Maintaining queries and protocol deviation database; perform serious adverse event and external data reconciliations
• Communicating with study monitors and other stakeholders to resolve data queries 
• Participating in site training and/or resolving inconsistencies at clinical sites as needed 
• Alignment of clinical data with reference assay results
• Performing interim statistical analyses for ongoing studies to ensure design criteria are being met and/or for publications
• Review study reports for accuracy
• Ensuring compliance with regulatory guidelines and industry standards 

Required qualifications include:

• A Bachelor of Science degree in a life science field or data science (biology, biomedical engineering, microbiology, or data science etc.) with 5+ years of relevant experience or a master’s degree in a related field with 2+ years of relevant experience
• Experience working in a GCP environment
• Experience with clinical data coordination and management 
• Experience with development and programming electronic data management systems, electronic case report forms and data edit checks
• Experience in development of data reports, listings, and dashboards
• Proficiency with data management and summary statistics software (e.g. GraphPad, Python, R, or JMP)
• Ability to interpret and communicate data
• Excellent written and oral communication
• Excellent organizational and time management skills
• Ability to work independently, as well as collaboratively
• Ability to multi-task

Preferred qualifications include:

• Experience with regulatory agencies and regulatory submissions
• Experience with immunodiagnostics 

Work environment information

• Prolonged periods sitting/standing at lab bench or computer
• May require occasional work onsite at clinical trial sites
• Our worksite includes a BSL 2 laboratory; however, this position is not expected to have any work responsibilities in the lab

This is a nonexempt, temporary position expected to last 12 months; however, there is the possibility of longer-term employment dependent upon funding. We are also willing to consider applicants who are interested in part-time employment. 

Wage/Benefits information

Gross Wage Range:  $31.73 - $42.79 per hour.
Starting wage will depend upon relevant experience and qualifications of the selected candidate. 

Full-time employees (and their families) may enroll in medical, dental, vision, Flexible Spending Account (FSA), and voluntary policies, which include supplemental life, accident, and critical illness. Full-time employees are covered by basic life insurance and long-term disability insurance. Employees may enroll in our company's 401k and/or Roth IRA retirement savings plans and Flexible Savings Account (FSA). Employees will accrue 2-weeks of paid vacation per year and a total of eleven paid holidays throughout the year, which includes the holiday observance of winter break at year end (the five weekdays between Christmas Day and New Year's Day).  NOTE: Part-time employees’ time-off benefits are prorated to work schedule as per the policies outlined in our employee handbook.