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Sarah Cannon Research Institute

Community-based oncology clinical research organization

Research Quality Manager

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeTennessee, USANo salary listedRemote

About the Job

Requirements

  • A bachelor's degree is required.
  • At least 3 years of work experience in Quality Assurance, Quality Management, or Quality Auditing is required, preferably in clinical research, healthcare, or life sciences.
  • Expertise in Good Clinical Practice (GCP), Food and Drug Administration (FDA) requirements, and other applicable regulations in a risk-based environment is required.

Responsibilities

  • Develop and maintain effective relationships with investigative sites, other SCRI departments, and colleagues.
  • Monitor and modify policies and procedures.
  • Use quality tools to assess study-operations quality indicators.
  • Monitor quality indicators for all sites using a risk-based approach and the Quality by Design (QBD) framework, prioritizing indicators according to severity and urgency.
  • Identify quality deficiencies and report them to SCRI directors and other appropriate colleagues.
  • Assist the business with developing and modifying process documents.
  • Assist with preparing for and hosting external audits.
  • Assist research staff in maintaining regulatory compliance.
  • Perform process or focused audits of research sites as needed, using research audit tools to ensure quality, and report findings to appropriate leadership.
  • Ensure timely and appropriate follow-up on deficiencies.
  • Communicate observations and deficiencies to the Site Director or Manager and study principal investigator, as appropriate.
  • Assist sites with root cause analysis and responses to external audits and corrective and preventive actions (CAPAs).
  • Maintain audit records and reports.
  • Communicate with clinical-trial monitors and auditors as needed.
  • Educate staff on quality-improvement methods and industry trends.

Desired Qualifications

  • A master's degree is preferred.
  • Experience in Quality Assurance, Quality Management, or Quality Auditing in clinical research, healthcare, or life sciences is preferred.

About the Company

Sarah Cannon Research Institute

Community-based oncology clinical research organization

Sarah Cannon Research Institute (SCRI) is a global oncology research organization that conducts cancer clinical trials in community settings, partnering with pharmaceutical and biotech sponsors, physicians, and patients to develop new treatments. It works as an oncology-focused contract research organization (CRO) and centralized site management organization (SMO), running trials across more than 200 locations with roughly 1,500 research physicians, and applies technology such as its Accelero platform to personalized-medicine studies. Over more than 30 years it has completed more than 900 first-in-human trials across early- to late-phase research. What sets SCRI apart is this community-based model paired with early-phase depth, which has helped advance most new cancer therapies the FDA approved in the past decade. The goal is to accelerate oncology research from early trials to approval and bring advanced cancer treatments to patients.

Company size
1-10
Company stage
Not listed
Total funding
Not listed
Headquarters
Beach Haven, NJ
Founded
Not listed

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