Clinical Research Document Coordinator @ Pattern Bioscience
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About Pattern Bioscience
At Pattern Bioscience, we’re tackling antibiotic resistance, one of the biggest public health challenges of our time. Using machine learning and microfluidics, the team quickly recognizes the bacteria causing an infection and predicts which drugs will cure it.
Our team shares a passion for our mission to improve the world’s most important health decisions and is equally invested in our people.
Role Overview: Clinical Research Document Coordinator
This 10-month contract position is designed for an organized and detail-oriented professional to manage documentation across internal lab sites supporting clinical trials and external partnerships. You will work closely with Clinical Affairs, Regulatory, Quality, and Microbiology teams.
Key Responsibilities
- Confirm case report form completion by site staff
- Coordinate workflow for physical documentation and EDC data entry
- Assemble clinical trial site binders and file documents in Trial Master Files
- Ensure document confidentiality and compliance with FDA, GCP, HIPAA, and other regulations
- Extract and verify complex clinical information
- Perform daily query resolution and data audits in the EDC system
- Create reports for tracking data quality metrics
- Collaborate with internal and external teams to resolve documentation queries
- Assist in preparing for regulatory inspections and audits
Who We’re Looking For
You should be exceptionally detail-oriented, enjoy organizing documents, and be eager to enter the clinical affairs field. Ideal candidates have:
- A Bachelor’s Degree in a scientific discipline or equivalent experience
- 1-2 years of relevant data entry or clinical research experience
- Knowledge of clinical research regulations (CFR, GCP, HIPAA)
- Familiarity with clinical lab operations, especially in microbiology
- Ability to manage small projects independently and communicate clearly
Key Skills/Competency
Clinical Research Document Coordinator, Documentation, Data Entry, EDC, Compliance, FDA, GCP, HIPAA, Microbiology, Quality Control
How to Get Hired at Pattern Bioscience
🎯 Tips for Getting Hired
- Research Pattern Bioscience's culture: Understand the mission and regulatory environment.
- Customize your resume: Highlight clinical data and EDC experience.
- Prepare detailed documentation samples: Showcase your organization skills.
- Practice compliance scenarios: Review FDA, GCP, and HIPAA guidelines.