Clinical Quality Consultant

HCA Nashville , TN 37201

Posted 1 week ago

SHIFT: Work From Home

SCHEDULE: Full-time

Sarah Cannon is the research arm of HCA's global cancer enterprise. Focused on advancing therapies for patients, it is one of the world's leading clinical research organizations conducting community-based clinical trials in oncology, cardiology and orthopedics through affiliations with a network of more than 1,000 physicians across the United States and United Kingdom.

We believe our success is dependent on a healthy work environment where staff members are the core of advancing therapies for patients and accelerating drug development. We apply the same compassion and commitment we have for our patients to our co-workers and colleagues and promote an entrepreneurial culture.

Benefits:

  • Tuition Reimbursement/Assistance Programs

  • Paid Personal Leave

  • 401k (100% annual match - 3%-9% of pay based on years of service)

  • Identity Theft Protection discounts

  • Auto, Home, and Life Insurance options

  • Adoption Assistance

  • Employee Stock Purchase Program (ESPP)

As the Clinical Quality Consultant, you are 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.

  • You will develop and maintain effective relationships with investigative sites and other SC departments and colleagues

  • You will monitor and modify policies and procedures for the investigative sites

  • You will utilize quality tools that assess the quality indicators of study operations

  • You will develop a calendar for monitoring quality indicators for all sites

  • You will prioritize quality indicators depending on severity/urgency

  • You will identify areas of deficiency in quality and reports those deficiencies to SC Directors and other appropriate colleagues

  • You will assist the investigative sites in development and modification of clinical research SOPs and Work Instructions

  • You will assist with preparation and hosting of external audits

  • You will assist research staff in maintaining FDA compliance

  • You will perform process / focused audits (as needed) of research sites utilizing research audit tools to ensure quality and reports audit findings to the appropriate leadership.

  • You will develop timelines to ensure timely and appropriate follow-up in areas of deficiency.

  • You will communicate observations and deficiencies to the Site Director / Manager and study PI, as appropriate.

  • You will assists sites with responses to external audits and CAPA development.

Qualifications

For this position, you must have:

  • An Associate's Degree (2 year program)

  • At least 3 years' experience in a clinical research organization/sponsoring company/biotech and/or quality department

  • Previous experience in a GxP environment

It is preferred that you have:

  • A Bachelor's Degree (4 year program)

  • 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

Do you find this opportunity compelling, if so we encourage you to apply? We promptly review all applications. If you are highly qualified you will hear from one of our recruiters. We are actively interviewing so apply today.

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.

Notice

Our Company's recruiters are here to help unlock the next possibility within your career and we take your candidate experience very seriously. During the recruitment process, no recruiter or employee will request financial or personal information (Social Security Number, credit card or bank information, etc.) from you via email. The recruiters will not email you from a public webmail client like Gmail or Yahoo Mail. If you feel suspicious of a job posting or job-related email, let us know by clicking here.

For questions about your job application or this site please contact HCAhrAnswers at 1-844-422-5627 option 1.

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Clinical Quality Consultant

HCA