Research Quality Improvement & Training Manager
Location:
Miami , Florida
Posted:
January 23, 2017
Reference:
16004504-en-us

McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Specialty Health, our products and services span the full continuum of specialty patient care. From the initial phases of a product life cycle and the distribution of specialty drugs, to fully integrated healthcare technology systems, practice management support, and ultimately to patient care in the communities where they live, we empower the community patient care delivery system by helping community practices advance the science, technology and quality of care.


We have a vision —that the long-term vibrancy of community care will be achieved through the leadership of physicians committed to clinical excellence and innovation, enabled by close collaboration with our organization and our deep clinical, operational and technological expertise.Every single McKesson employee contributes to our mission—by joining McKesson Specialty Health you act as a catalyst in a chain of events that helps millions of people all over the globe. You’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.


Join our team of leaders to begin a rewarding career.



Current Need

Ensures planning, coordination, control, and continuous improvement of processes and methods are 
established to control the quality of studies conducted at research site specific to, but not limited to US 
Oncology Research trials. Facilitates a program focusing on continuous improvement using approved 
tools, design control, validations, and ensuring adherence to GCP, FDA Regulatory requirements, 
Industry Guidelines, local regulations, along with site policies and procedures for the conduct of clinical 
trials. Trains and mentors members of the clinical research team on quality improvement and self auditing 
processes. Works closely with the site leaders, site research team, physicians, US Oncology 
Research, and other supporting areas/development teams, to help ensure active participation in 
continuous quality improvement activities. Prior experience in research quality assurance and training 
required. 


Position Description

Actively lead or assist activities in the areas of Internal Quality Audits, CAPA (Corrective and Preventive Actions), Production support, Quality Management Reviews, and Quality Audits specific to, but not limited to US Oncology Research (USOR) clinical trials. Support the development of GCP/ICH compliant processes which control the quality of work and clinical trials conducted at research site.

Lead study review activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines, FDA regulations, and site policies and procedures. Lead or assist with identifying non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology while maintaining compliance with applicable study protocols, Quality System Regulations and or ISO standards where applicable.

Conducts new hire staff training on USOR processes and SOPs. Provide ongoing staff training and development for all staff to ensure high quality data submission and protocol adherence.

Reviews site audit reports with practice-based research staff and administration and works collaboratively with USOR Central and Site Service Manager to execute action plans.

Completes and submits written research QA site audit reports to practice QA Coordinator and practice research leaders on a monthly basis.

Serves as the on-site liaison between USOR and practice for all issues related to the conduct of clinical research and USOR clinical trials.

Qualifications

Minimum Requirements
5+ years quality assurance or related experience and 2+ years managerial experience


Critical Skills

Bachelor’s degree in clinical or scientific discipline.  Business or related degree acceptable with appropriate experience

Minimum of 5 years experience in an oncology and/or research setting.
Proficiency with computer systems and Microsoft Office Suite (Outlook, Word, Power Point,
and Excel) required
Knowledge of GCP, ICH and FDA guidelines
Experience with collecting and/or reviewing data for clinical research studies
Experience with training and development.


Additional Knowledge & Skills
Thorough knowledge of quality assurance policies, practices and systems, and demonstrates leadership skills
CCRA or CCRC preferred./ Knowledge of oncology and related disciplines and treatment patterns preferred
Valid state licensure applicable to clinical background


Education
4-year degree in related field or equivalent experience


Physical Requirements
General Office Demands
Up to 20% travel


Benefits & Company Statement
McKesson believes superior performance – individual and team – that helps us drive innovations and solutions to promote better health should be recognized and rewarded. We provide a competitive compensation program to attract, retain and motivate a high-performance workforce, and it’s flexible enough to meet the different needs of our diverse employee population.

We are in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. We partner with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting.

But we can’t do it without you. Every single McKesson employee contributes to our mission—whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. Talented, compassionate people are the future of our company—and of healthcare. At McKesson, you’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.

McKesson is an equal opportunity and affirmative action employer – minorities/females/veterans/persons with disabilities.

Qualified applicants will not be disqualified from consideration for employment based upon criminal history.

Agency Statement
No agencies please.

A little about us:
McKesson is in business for better health.

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