Clinical Research Document Coordinator na Pattern Bioscience

At Pattern Bioscience, we’re tackling antibiotic resistance, one of the biggest public health challenges of our time.  We use machine learning and microfluidics to quickly recognize the bacteria causing an infection and to predict which drugs will cure the infection.

Our team is brought together by shared passion for our mission to improve the world’s most important health decisions. However, we’re not only invested in combating antibiotic resistance; we’re also invested in our people. 

We are seeking a Clinical Research Document Coordinator to organize and manage documentation for multiple internal lab sites to support clinical trials and other external partnerships for a period of ten months. In this role, you will interact with groups in Clinical Affairs, Regulatory, Quality, and Microbiology to ensure necessary protocol documents are provided to teams and data generated during testing is captured compliantly. This role is for you possess a high attention to detail, love organizing, and are eager to enter the world of clinical affairs and the fight against antimicrobial resistance.  

How You Will Contribute

• Confirm completion of case report forms by site staff
• Coordinate the workflow of physical documentation
• Assemble clinical trial site binders
• File documentation into internal sites’ Trial Master Files
• Maintain document confidentiality at all times, understand and comply with the appropriate sponsor requirements and regulations which includes the Food and Drug Administration, Good Clinical Practices, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures
• Obtain and abstract complex clinical information from multiple sources for specimens. Verify all records are readable, accurate, and complete
• Responsible for Electronic Data Capture (EDC) data entry and management which is essential for daily clinical research operations
• Perform daily EDC query resolution with minimal errors
• Assist in the creation of data management process for quality control and assurance
• Perform auditing and review of EDC entries to ensure compliance standards are maintained
• Assist in preparing for Regulatory Agency inspections and sponsor audits
• Maintain awareness of details of clinical data to identify missing or inaccurate data; track data inconsistencies for Clinical Research Operations team to review and report accordingly
• Create reports to track data and quality metrics
• Collaborate with internal site staff and external personnel to resolve queries to ensure clinical data quality and compliance
• Coordinate multiple complex projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume
• Collaborate with study staff in the preparation of study audits, quality reviews, and monitor visits
• Assist with the implementation of quality assurance data management plans and other auditing processes as needed

We'd Love to Hear from You If You

• Are exceptionally detail-oriented and organized with an affinity for efficiency
• Manage small projects and work independently
• Understand and interpret clinical research protocols and other applicable sponsor documents
• Enjoy repetitive activities while identifying opportunities for process improvement
• Communicate clearly and proactively
• Possess basic clinical lab knowledge, especially clinical microbiology
• Plan and execute projects in an efficient and timely way ensuring alignment from relevant team members and to organizational goals
• Resourcefully navigate digital and physical document storage systems and other software-related tools

Desired Education and Experience

• Bachelor’s Degree in scientific area of study or equivalent combination of education, training, and experience
• 1-2 years of previous data entry experience as a clinical research coordinator, clinical research assistant or data entry specialist for clinical trials
• Knowledge of regulations governing clinical research (CFR, GCP, HIPAA)

Benefits 

• Medical, Dental and Vision Insurance 
• PTO 
• Career development 
• The opportunity to make a global impact and pioneer solutions 

Check out our Careers page to see all our benefits and what it’s like working with us. https://pattern.bio/join-us/ 

All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.