Blue Signal Search
Our client, a leading non-profit healthcare system in New Jersey, is looking to add a Quality Manager of Clinical Research to manage the Quality team while ensuring department is compliant with business standards and Federal regulations. The Quality Manager of Clinical Research will serve as a point of contact between team members, investigators, and other vendors.
This Role Offers:
• Competitive wage plus great benefits – medical/dental/vision, 401(k) match, etc.
• A company viewed as leader in healthcare humanitarianism, taking pride in serving those in need.
• Opportunities for top-tier learning programs that inspire, connect, and develop their team.
• Culture of high performance and quality customer care.
• Work to provide the motivation, tools, steps, and community that will produce lasting outcomes.
• High level of involvement in cutting edge clinical research that is set to change the way healthcare providers approach and care for cancer.
• Manage Quality personnel and oversee the hiring, onboarding, and training of staff.
• Oversight of preparations related to regulatory audits and site inspections.
• Perform internal audits to evaluate clinical trial conduct and ensure trials are properly maintained and that regulatory files and processes are up to date.
• Prepare and submit documentation related to the regulatory review for clinical studies.
• Maintain medical laboratory equipment performance by establishing quality standards; developing operations, quality, and troubleshooting procedures; ensuring staff compliance.
• Implement new programs, methods, instrumentation, and procedures by investigating alternatives; preparing proposals; developing and performing parallel testing; monitoring progress.
• Follow all Standard Operating Procedures to ensure safety and quality standards.
• Work alongside team of group leaders to create and implement strategy and initiatives for growth and overall operational excellence.
• 3+ years of Quality experience in a healthcare/clinical environment. Experience with oncology clinical trials required.
• 3+ years of progressive leadership experience.
• Bachelor’s degree in related science field. Master’s preferred.
• ACRP or SOCRA certification required.
• Proven experience with research as well as knowledge of best practices for HIPAA, consent, GCP, FDA, SOP, safety monitoring, and others.
• Strong communication skills and ability to collaborate with a team.
• Commitment to helping others, while displaying a positive attitude.
• Proficient knowledge of the Google Suite of applications and other data capture systems.
To apply for this job please visit www.bluesignal.com.