Clinical Trial and Clinical Quality Specialist
Remote /
Clinical, Regulatory, and Quality Affairs – Clinical Affairs /
Full-time
/ Remote
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.
We are seeking a dynamic individual with an eye for process optimization to join our team as a Clinical Trial and Clinical Quality Specialist. In this role, you will provide operational support for our clinical studies, as well as interact with our Quality, R&D, Hardware, Manufacturing, Microbiology, and Software teams, clinical study sites, and external partners. Your expertise will contribute to study development and execution, and you will help ensure that clinical trials are conducted, monitored, and documented according to federal regulations and GCP. Below you will find the immediate ways you’ll be able to make an impact in addition to long-term outcomes and responsibilities.
90-Day Goals
- Contribute to the design of upcoming clinical trial
- Assist in coordinating with sites for contracting and budgeting for upcoming studies and prospective specimen enrollment collaborations
- Organize clinical study trial master files
- Learn to build and audit studies in the electronic data capture system
- Contribute to validation of an electronic signature process
6-Month Goals
- Support clinical study initiation at external sites
- Support data collection and curation for FDA Breakthrough Device applications
- Work with Quality and Clinical Affairs team to develop internal clinical trials SOPs and Quality Management System documentation
- Build strong relationships/credibility with other internal teams and external clinical sites
How You Will Contribute
- Provide operational support for clinical trials including tracking and maintaining audit-ready clinical trial documentation, assisting in the creation of study specific tools and templates, and ensuring the clinical trials comply with all regulatory/federal guidelines
- Participate in study design and execution by contributing operational expertise and experience
- Provide management and support of quality related tasks and systems related to clinical studies
- Contribute to SIVs and close-out visits
- Support CRAs in monitoring sites for clinical trials
- Coordinate IRB, budgeting, and contracting documentation for clinical and pre-clinical study sites
We'd Love to Hear from You If You
- Have a strong attention to detail for the generation and review of high-quality clinical study documentation including overall trial master files, electronic data capture system, and SOPs
- Have excellent written and oral communication skills
- Are able to identify and implement methods to improve the efficiency of processes and workflows while maintaining quality
- Have excellent planning and organizational skills and are detail-oriented
- Are insightful, capable of working independently, and enjoy working in a collaborative setting
- Are a continuous learner
Desired Education and Experience
- Bachelor’s degree in a technical or life science field
- Minimum 5 years’ experience working on IVD clinical trials with at least some of the experience related to infectious diseases
- Experience managing clinical trial documentation/clinical trial master files
- Have a strong understanding of Quality, GCP, and FDA Regulatory requirements for executing IVD/device clinical trials
- Experience with electronic data capture (EDC) systems
- Experience reviewing and coordinating contracts and IRB approvals for external studies
Skills or Attributes Considered a Plus
- Knowledge of regulatory requirements for other agencies such as IVDR, UK-CA, etc.
- SOCRA CCRP or equivalent
- Experience in clinical microbiology
- Experience building in EDC systems and conducting audits or user testing of EDC
Instead of customizing a cover letter or rewriting a resume to try to feature the attributes and experience this role is seeking, we invite you to fill out the application questions. The hiring manager reviews every response, and the questions allow you to highlight the qualifications that make you a great fit for the role.
Join us! We're excited for what you can bring to our team. Here are a few things we provide to make sure you have a great experience. Learn more about our team by visiting our website.
Benefits
* Health insurance
* 401k Matching
* Paid Time Off
* The opportunity to make a global impact
To fulfill our mission and build world-changing technology, we’ve put together a diverse, multi-disciplinary top-notch team, a culture of innovation, learning, adaptability, and excellence and environment where people love coming to work.
We value diversity on our teams. 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.
