Senior Clinical Quality Associate

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About the role

Curebase is seeking a Sr Clinical Quality Associate  who will thrive in a quickly scaling healthcare technology environment. This role will be  responsible for helping lead risk-based quality management (RBQM) surveillance of Clinical Operations activities, with an emphasis on risks impacting patients' safety and data quality, to ensure compliance with internal SOPs and applicable regulations (e.g., ICH-GCP, US CFR) related to clinical quality. This role reports directly to the Director of Quality.

What you’ll do

  • Provide advice and support regarding interpretation of internal SOPs and applicable regulations (e.g., ICH-GCP, US CFR) to ensure quality and regulatory compliance
  • Oversee and conduct quality assurance reviews of clinical trial documentation (e.g., essential documents, clinical database, training records) to confirm adequate quality 
  • Perform initial and recurring risk identification, assessment, and mitigation activities
  • Manage non-compliance (e.g., regulatory, protocol, SOP) and clinical quality issues, ensuring appropriate actions and documentation (e.g., incident reports, CAPAs) 
  • In collaboration with Clinical Operations, ensure trials are inspection ready at all times
  • Host and participate in activities related to client audits and regulatory inspections 
  • Participate in the evaluation and qualification of external partners (e.g., clinical sites, vendors), including conducting audits (remote or in-person) on an as needed basis
  • Contribute to the oversight and maintenance of controlled documents related to clinical quality assurance within the Quality Management System
  • Support the development and implementation of SOPs related to clinical quality management
  • Assist in tracking and assessment of clinical quality compliance metrics to identify risks and trends across clinical trials
  • Collaborate with Clinical Operations in the development of study-level Clinical Monitoring Plans
  • Develop and implement study-specific Quality Management Plans, as applicable
  • Review draft clinical trial documents (e.g., protocol, consent) for quality and regulatory compliance on an as needed basis
  • Lead the identification and implementation of clinical quality improvement initiatives 

About you

  • Bachelor’s degree in life sciences or related field
  • Minimum of four years’ experience in clinical research, including a minimum of two years’ of experience working in a role focused on quality management of clinical trials
  • Well-versed in risked-based quality management (RBQM) and relevant ICH-GCP, US CFR, and HIPAA regulations
  • Strong understanding of Quality Management Systems and CAPA process
  • Possess experience in participating in audits and regulatory inspections. Ability to work with Director of Quality in coordinating responses in relation to audit reports and analyzing audit findings
  • Proven ability to work well with a remote-based team
  • Ability to excel in a fast-paced and rapidly changing environment
  • Tech-savvy with the skills and ability to apply new systems to her/his everyday tasks
  • Understand the importance of adaptability and eagerness to learn and adapt to technology changes over time
  • Willingness to travel for job-related activities if required (expected travel for this position is


About Curebase

Curebase is reinventing decentralized clinical trials to help the vast majority of potential patients that currently cannot access clinical research. Our vision is that any patient, no matter where they are located, should be able to participate in clinical trials at home and with their own doctors. This is made possible through a unique suite of tools Curebase’s has designed to engage patients in clinical trials across all settings, be it at home, at their local clinic, or other places in their community.  

This starts with Curebase’s leading decentralized clinical trial software platform that is an all-in-one, purpose built eClinical software system, with every tool needed to manage and collect data for decentralized clinical trials. This includes ePRO, eCOA, eConsent, Telemedicine, and much more. Curebase also offers a virtual research site, complete with virtual investigators, research coordinators, mobile nursing, and other healthcare staff that administer care to patients where convenient for them, just like any other research site, but with the ability to stand up anywhere and with greater patient convenience and reach. Notably, Curebase is the pioneer of the “BYOP” or Bring Your Own Physician model, allowing patients to use their own doctors to participate in clinical trials. 

We are reinventing a $45B market, enabling drug and device companies to increase the volume, quality, and speed of data collection regardless of patients’ physical location. COVID-19 tailwinds have created massive demand for telemedicine and home-based trials, with two new FDA guidance letters and industry-wide adoption of remote remote research that will only accelerate in the years to come. You can learn more about Curebase and our next stage of growth in Crunchbase, Fierce Biotech, and MedCity News!

Benefits

  • 100% coverage for Medical / Dental / Vision
  • 401k plan
  • Flexible PTO
  • Passionate team dedicated to making a positive impact
  • Unlimited career growth opportunity
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Location

CA

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