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Clinical Quality Consultant

Nashville, TN, United States

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Description

SHIFT: No Weekends

SCHEDULE: Full-time

Clinical Quality Consultant

 

Sarah Cannon, the Cancer Institute of HCA Healthcare, offers integrated cancer services with convenient access to cutting-edge therapies for those facing cancer in communities across the United States and United Kingdom. Sarah Cannon’s cancer programs include individualized patient navigation provided by oncology-trained nurses, more than 1,000 stem cell transplants performed annually throughout the Sarah Cannon Blood Cancer Network, hundreds of clinical trials, and molecular profiling capabilities. Through its services, Sarah Cannon is providing state-of-the-art cancer care close to home for hundreds of thousands of patients, a number unmatched by any single cancer center.

 

By bringing together a network of globally-recognized cancer experts, we are collaborating and sharing best practices that address every aspect of the cancer journey, from screening and diagnosis through treatment and survivorship.

 

Sarah Cannon Research Institute is the research arm of HCA Healthcare’s global cancer institute, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world’s leading clinical research organizations conducting community-based clinical trials throughout the United States and United Kingdom. Sarah Cannon’s network of strategic sites includes more than 275 physicians who engage in research. The organization has led more than 300 first-in-man clinical trials since its inception in 1993, and has been a clinical trial leader in the majority of approved cancer therapies over the last 10 years.

 

Benefits:
We offer you an excellent total compensation package, including competitive salary, excellent benefit package and growth opportunities. We believe in our team and your ability to do excellent work with us. Your benefits include 401k, PTO medical, dental, flex spending, life, disability, tuition reimbursement, employee discount program, employee stock purchase program and student loan repayment. We would love to talk to you about this fantastic opportunity.



Summary of Position:

Responsible for implementing the quality assurance program, managing and performing consult visits at investigative sites, assisting with onsite external audits and inspections, and providing routine quality support for assigned investigative sites.

 
Duties and Responsibilities
 
Duties include but are not limited to:
  • Develops and maintains effective relationships with investigative sites and other SC departments and colleagues
  • Monitors and modifies policies and procedures for the investigative sites
  • Utilizes quality tools that assess the quality indicators of study operations
  • Develops a calendar for monitoring quality indicators for all sites
  • Prioritizes quality indicators depending on severity/urgency
  • Identifies areas of deficiency in quality and reports those deficiencies to SC Directors and other appropriate colleagues
  • Assists the investigative sites in development and modification of clinical research SOPs and Work Instructions
  • Assists with preparation and hosting of external audits
  • Assists research staff in maintaining FDA compliance
  • Performs process / focused audits (as needed) of research sites utilizing research audit tools to ensure quality and reports audit findings to the appropriate leadership.
  • Develops time line to ensure timely and appropriate follow-up in areas of deficiency.
  • Communicates observations and deficiencies to the Site Director / Manager and study PI, as appropriate.
  • Assists sites with responses to external audits and CAPA development.
  • Maintains records of audits and reports.
  • Communicates with monitors and auditors of clinical trials, as needed.
  • Educates staff in quality improvement methods and industry trends
  • Performs related work as required
  • All other duties as assigned
  • Travel, as assigned 
Competencies

Knowledge: A body of information needed to perform a tasks; May be obtained through education, training or experience

  • FDA Regulations and GCP Guidelines
  • Pharmaceutical, biologics, and/or medical device industry

Skills: The proficiency to perform a certain task

  • Professional writing and communication skills
  • Interpersonal skills
  • Computer skills, including MS Word, Excel, Outlook; electronic data capture systems, electronic quality management systems
  • Problem solving skills

Abilities: An underlying, enduring trait useful for performing duties

  • Customer-focused
  • Relationship building
  • Analytical
  • Organized, ability to prioritize
  • Detail-oriented and meticulous

Qualifications

Minimum Qualifications

Education:
Minimum Required: Associates Degree (2 year program)

Preferred: Bachelor’s Degree (4 year program)

 

Experience:

Minimum Required:

  • At least 3 years’ experience in a clinical research organization/sponsoring company/biotech and/or quality department
  • Previous experience in a GxP environment
Preferred:
  • Experience in a clinical trial environment working with a CRO, sponsor or investigative research site environments
  • Demonstrated leadership skills
  • Prior experience mentoring and/or training less senior team members
  • Research certification

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender,sexual orientation, age, marital status, veteran status, or disability status.


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Sarah Cannon Network
Facility: Sarah Cannon Network
Job ID: 25320-5905
Category: Case Management
Contract: Full-time
Shift: No Weekends
Job Class: Regular

Apply Now
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