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 missionby 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.
This position is responsible for overseeing the accreditation of the Institutional Review Board (IRB) through AAHRPP, with broad responsibility for writing policies, procedures, and guidance. This position provides technical or topical instruction, guidance and problem resolution for staff, IRB members, researchers and other involved departments as resource related federal, state and institutional guidelines related to protection of human research subjects.
Comprehensive understanding of US Oncology Research processes and operational goals. Adheres to the US Oncology Compliance Program, including the Code of Ethics and Business Standards.
The ideal candidate will have experience in the conduct and/or oversight of human subject's research, and will be able to work independently, as well as within a team approach.
Maintains current knowledge of Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) regulations, guidance and standards, as well as Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation standards.
Serves as the lead contact for reviews and inquiries from the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
Assesses current institutional policies, processes and practices for alignment with federal and state regulations, local laws, Institutional policies and procedures, AAHRPP accreditation standards and best ethical practices related to human subject's research.
Develops, recommends, and improves policies, procedures, and practices to streamline workflow of research operational processes and improve likelihood of obtaining accreditation. Analyzes complex data, draws meaningful conclusions, and reports conclusions in a clear, understandable format to all stakeholders at all levels. Participates in drafting new policies and procedures for the department and makes recommendations improvement of department activities.
Collaborates with research department staff and other units to conduct gap analysis, policy/form development, education/communication development and delivery, preparation of AAHRPP applications, coordinating the AAHRPP site visit, and coordinating and submitting any additional documentation to AAHRPP such as responses to issues raised during site visits or annual reports.
Works with applicable units to assess and implement, and maintain AAHRPP standards, which include assessing AAHRPP standards and identifying which business units, policies, procedures, and forms respond to the standards. Reports issues to the IRB Manager and Director of Research Operations.
Maintains and measures project performance by maintaining timelines and by using tracking/analysis tools. Develops reports on project status on a bi-weekly basis to IRB Manager and Director of Research Operations to ensure target initiatives are being met.
Other Duties as required.
Prepares, maintains and updates IRB files per FDA guidelines. Ensures file is continuously updated and prepared for audits. Makes files available for audit inspections. Responds to and resolves queries as necessary.
Acts as a delegate in the absence of the IRB Manager.
Minimum Job Qualifications:
Minimum3 year experience in clinical research, human subjects research, regulatory complianceand/or IRB experience preferred.
Must have a strong knowledge in human subject research, federalregulation governing research, including ICH-GCP, HIPAA regulations, andprevious experience with AAHRPP accreditation standards.
Projectmanagement or supervisor experience preferred.
Abilityto learn complex concepts (regulatory, ethical and scientific) and operate at ahigh level of interaction with researchers and board members.
Mustbe skilled in interpersonal relationships and oral and written communicationand be able to deal with high volumes and rigid deadlines.
Ademonstrated working knowledge of the federal regulations governing humansubjects research is required.
Sufficientprofessional experience, adequate education, and sound judgment to comprehend,interpret, and analyze publications and reports concerning applicable policies,procedures and regulations on human subject research issues.
Ability to work independently and as part of a team inter-dependentlywith co-workers.
Ability to effectively plan and organize projects impacting thework of others.
Education/Training Bachelor's degree inrelated field or High School Diploma (or equivalent) and minimum four yearsprofessional work experience, required. CIP (Certified IRB Professional) preferred.
Travel: Up to 15%
Environment Workis performed in an office environment. Thework environment characteristics described here are representative of those anemployee encounters while performing the essential functions of this job.
Requires significant interaction withclinical and corporate staff. Reasonableaccommodations may be made to enable individuals with disabilities to performthe essential functions.
Physical Requirements (Lifting, standing, etc.) Thephysical demands described here are representative of those that must be met byan employee to successfully perform the essential functions of this job.
Reasonable accommodations may be made toenable individuals with disabilities to perform the essential functions.
While performing the duties of this job, theemployee is regularly required to sit and use hands to finger, handle orfeel. The employee is occasionallyrequired to stand, walk and reach with hands and arms. The employee must occasionally lift and/ormove up to 40 pounds. Requires visionand hearing corrected to normal ranges.
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 missionwhatever 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 companyand 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.
No agencies please.