McKesson Corporation is a Fortune 8 company and is one of the largest providers of healthcare supply chain management solutions, retail pharmacy, medical & pharmaceutical supplies, healthcare technology, community oncology and specialty care in the United States with revenues of $231 billion in 2020. The company was founded in 1833 by John McKesson and Charles Olcott in New York with a focus on importing and wholesaling pharmaceutical products. United by our ICARE shared principles, McKesson's 80,000 employees work together every day to make better care possible around the globe - one product, one partner, one patient at a time.
Demonstrates fundamental understanding of US Oncology Clinical Research processes, business and operational goals.
Collaborates with team initiatives and serves as support for senior members of the team to deliver action items and products to our sites, IRB and sponsor/CRO clients.
Understands the importance of building relationships at McKesson with key stakeholder and business partners.
Ensures accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
Analyzes regulatory requirements, identifying potential conflicts, and have thorough knowledge and ability to apply federal regulations and USOR policies.
Maintains awareness, excellent comprehension and appropriate application of relevant regulations.
Ensures all assigned clinical trial regulatory obligations are managed compliantly with FDA regulations while adhering to USOR processes and procedures.
Maintains compliance and integrity of study trial master file in paper/electronic formats.
Inspects documents for compliance, assures that file is continuously updated and prepared for audits.
Hosts and prepares interim monitoring visits to external clients and speaks to outstanding issues and works to resolve them.
Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Clinical Operations and IRB.
Provides local expertise to internal teams during initial and on-going project timelines planning.
Monitor project development on an ongoing basis and implement changes as needed.
Manages, completes, reviews, and submits protocol submissions from study start-up through study termination, including amendments, safety reports, renewals, deviations, etc.
Prepares and negotiates language in Inform Consent Forms to assure adherence to protocol and IRB requirements.
Reviews and evaluates study procedures to determine whether supporting documents (i.e. patient diaries and surveys) are required.
Strong problem solving and time management, including ability to adapt to frequent changes in work assignments, prioritize, and manage competing priorities and deadlines.
Conduct regulatory reviews prior to committee consideration to ensure submitted research is in compliance with submission requirements with state, Federal regulations and USOR policies. Facilitates IRB approval and renewal of clinical protocols, IDB, advertising materials, consent forms and other items required by federal research regulations
Notifies IRB of trial changes, enrollment status and protocol deviations.
Collaborates with representatives from multiple departments including project management, finance and IRB; research staff including the network principal investigator; and external clients including study sponsor and sponsor's authorized representatives to analyze patient informed consent document for accuracy, consistency and adherence to study protocol, budget and regulatory requirements.
Other duties as assigned
Minimum Job Qualifications:
Education/Training - Bachelor's degree in related field required
Business Experience - 2 year Clinical research knowledge is required, 1 year regulatory specialist experience required, 1 year oncology experience preferred. Handles day to day work challenges confidently; is willing and able to adjust to multiple demands, shifting priorities, ambiguity and rapid change; shows resilience in the face of constraints, frustrations, or adversity; demonstrates flexibility.
Specialized Knowledge/Skills - Proficiency with computer systems and Microsoft Office (Outlook, Word, Power Point, and Excel) required. Shows Work Commitment: Sets high standards of performance; pursues aggressive goals and works efficiently to achieve them.
Discretionary decision-making and independent judgment skills. Strong problem solving and time management, including ability to adapt to frequent changes in work assignments, prioritize, and manage competing priorities and deadlines. Must be precise, thorough, reliable, and perform daily activities with minimal supervision.
Knowledge of clinical research process and regulations. Demonstrated analytical skills; ability to create ad hoc reports, tracking tools, and professional documents; and the ability to interpret and apply complex government regulations.
We take pride in our culture of connection and believe in a workplace where everyone can be their full, authentic self. We welcome and encourage veterans, individuals with disabilities and others with diverse perspectives to join our growing team. Your unique perspective and experience are valuable assets that can translate into a rewarding career path with us. Apply to join our team and help shape the future of healthcare!
McKesson is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.Qualified applicants will not be disqualified from consideration for employment based upon criminal history.
McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to McKessonTalentAcquisition@mckesson.com . Resumes or CVs submitted to this email box will not be accepted.
Current employees must apply through the internal career site.
Join us at McKesson!
Internal Number: JR0044812
About McKesson Corporation
We deliver careers with purpose and potential. Our focus on better health starts with creating an inclusive environment with strong values where you can build a fulfilling career. You can count on us to provide you with resources and opportunities to grow and be your best, while contributing to our pursuit of improving lives. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient. We work to distribute medical supplies, bandages, syringes, vials of flu vaccine, and pharmaceutical drugs to help real patients like Jack, an eight-year-old boy battling cancer. We take that job seriously. Together, the work we do is shaping the future of healthcare. If you are passionate about combining a meaningful career with a balanced life, join us on this journey and apply for a job with McKesson today. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient.