Background

Trialspark is a technology company that brings new treatments to patients faster by reimagining the clinical trial process.Today, a clinical trial can cost more than $100M and take 10 years to complete, bottlenecking the development of new treatments for patients. We’re fundamentally changing how trials are run, rethinking the trial process both from a technology and operational perspective.

Job Description

As a Quality Assurance Operations Associate you will be reporting to the Director, QA Operations. The Quality Assurance Operations Associate will assist the Quality Assurance team in the day-to-day management and oversight of our Quality Management System, Document Management System and Learning Management System assisting on the compliance and maintenance activities.

Duties include, but are not limited to:

• Assist in preparation of internal (clinical sites, internal process) and external (vendor) audits conducted by TrialSpark QA. 
• Assist in developing corrective and preventive actions/plans based on audit findings (internal, external) or non-compliances in support of continuous process improvement initiatives across the organization. 
• Assist in managing Document Management System /Learning Management System workflows. Assist in system migration workflows and developing associates standard operating procedures and work instructions as required. 
• Support in the development of Quality Assurance dashboards, quality metrics (Key Quality Indicators) , management reports as needed.
• Assist in the planning. preparation and conduct of all sponsor audits (clinical site GCP and company offices) and /or Health Authority (i.e.: FDA) inspections.
• Support training, lessons learned initiatives as required across the organization in driving high quality deliverables and outputs. 
• Manage and oversee various QA department administrative tasks as needed.

Relevant Experience:

• Bachelor’s Degree in life sciences preferred. 
• Prior experience in managing quality systems (controlled documents, training platforms, learners), Document Management Systems (eISF,eTMF).
• Previous experience in managing clinical site operations. 

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.