Works in compliance with principles of Good Clinical Practice and applicable federal, state, and local regulations. Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards.
Serve as the clinical point person managing protocol start up. Manage the study start-up process including site list delivery, team process report completion, project map with clear timelines for the project and all supporting team members accountable to the project. Responsible to outline expectations to internal teams and sponsors/vendor to ensure successful study implementation. Protocol Review: review clinical trials for scientific merit as well as operational review for staff working in an outpatient community-based setting. Review protocol procedures for standard of care vs research related charges. Provide all supporting team members with the information and contacts needed in order to complete tasks. Responsible for communication and escalation of study related issues as required. Work cross functionally to ensure clinical program timelines and goals are met. May engage in trial execution. Mentor Clinical Trial Associate. Ensure trial adherence to ICH/GCP/local regulations. Communicate effectively with internal and external study personnel (investigative staff, vendors, etc.)
Vendor identification and management (e.g., CROs, IVRS, Reading Centers, etc.); including participating in negotiation of vendor scope of work, budgets, performance management, issue resolution, and quality assessments. Ensure availability of clinical/non-clinical supplies
Ensure internal and external systems are updated in a timely manner (CTMS, clinicaltrials.gov). Identify, address, and communicate quality and compliance concerns. Works with the regional staff and quality assurance team to facilitate quality improvement programs (i.e. plans of actions) related to clinical trials
Participate in development and testing of clinical systems (laboratory, data entry, IVRS, etc.). Provide study-specific direction and mentoring to other staff as appropriate
Minimum of three years of clinical research experience
Prior oncology research experience
Study management/project management experience
Additional Knowledge and Skills
Attention to detail, solid execution, meeting aggressive timelines, strong interpersonal skills and team player. Excellent verbal and written communication skills
Must be pro-active team player, flexible, and open to change.
Works in compliance with principles of Good Clinical Practice and applicable federal, state, and local regulations
Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards
Experience developing study plans and budgets including risk mitigation strategies
Experience in multiple phases of research preferred
Bachelor's degree in clinical or scientific discipline (or equivalent experience)
General Office, may require travel by air or automobile approximately up to 10% of the time
Large percent of time performing computer-based work is required
Must be authorized to work in the US. Sponsorship is not available for this position.
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 [email protected] . 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: JR0041675
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.