McKesson Regulatory Specialist in The Woodlands, Texas
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.
Under direct supervision, coordinates the regulatory and Institutional Review Board activities of clinical research being conducted within the US Oncology Research Network. Collaborates with internal research teams and external pharmaceutical (sponsor) clients to ensure compliance with federal regulations. Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards.
Key Responsibilities 100%:
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. Receives, reviews and analyzes Serious Adverse Event reporting requirements received from sponsor ensuring that the information matches content in the research protocol and compiles the Safety Clinical Trial Information form which guides site staff in appropriate reporting requirement. Receives Serious Adverse Event reports from sites in a variety of sponsor mandated formats and critically reviews the report to be able to provide accurate and timely reporting of Serious Adverse Events to the IRB for review. 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, identify 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. (25%)
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. Ensures 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. (25%)
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. (20%)
High level of competency with computer software, including databases and database management, spreadsheet applications, development and presentation of PowerPoint slides, and training/educational materials. Creates e-signature templates and coordinates collection of required documentation from research sites in accordance with FDA and trial sponsor specifications and tracks collection progress through internal tracking systems. Communicates daily with sites to get documentation completed. Escalates to manager for non-responsive sites. Reviews each document for regulatory compliance, accepts or rejects documents. Creates and executes regulatory strategies for clinical trial applications. Exercises good judgment when making decisions. Perform quality control of documents provided by sites. (10%)
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
- Other duties as assigned (10%)
2 years of Clinical Research knowledge
1 year of regulatory specialist experience
1 year of Oncology experience is preferred
Possesses up to date knowledge of the profession and industry; accesses and uses other expert resources when appropriate
Proficiency with computer systems and Microsoft Office (Outlook, Word, Power Point, and Excel) required.
Strong problem solving and time management, including ability to adapt to frequent changes in work assignments, prioritize, and manage competing priorities and deadlines.
Knowledge of clinical research process and regulations a plus
Additional Knowledge & Skills
Shows Work Commitment: Sets high standards of performance; pursues aggressive goals and works efficiently to achieve them.
Discretionary decision-making and independent judgment skills.
Must be precise, thorough, reliable, and perform daily activities with minimal supervision.
Demonstrated analytical skills; ability to create ad hoc reports, tracking tools, and professional documents; and the ability to interpret and apply complex government regulations.
Bachelor's degree in related field required.
General Office Demands
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.
No agencies please.
Organization: McKesson Specialty Health
Title: Regulatory Specialist
Location: Texas-The Woodlands
Requisition ID: 18006931