Manager of Research EMR Operations

About the role

The Manager of Research EMR Operations oversees the team performing clinical interpretation of protocols and translates this into detailed schedules of events. Key responsibilities include managing the team, developing departmental relationships, reviewing protocol builds, managing amendments, serving as a scientific expert, validating protocol interpretations, preparing for protocol review committees, creating and updating clinical operation worksheets, attending protocol review committees, converting protocols into schedules, reviewing amendments, updating EMR systems, providing clinical interpretation, and guiding clinical educators.

Responsibilities

• Manage the team of EMR Analysts to ensure productivity, quality, and timeline metrics are met.
• Develop relationships between departments to ensure protocol impacts are communicated out.
• Review protocol builds for accuracy, thoroughness, compliance, and sufficiency.
• Manage the amendment intake process, acting as a single point of contact for the team.
• Serve as a scientific and clinical expert in interpreting clinical trial protocols.
• Work directly with Scientific Director, Physicians, and Program Managers to validate proper protocol interpretation.
• Create and update the protocol-specific Clinical Operation worksheet with pertinent study information.
• Attend the Sarah Cannon Clinical Operations Protocol Review Committee to capture details presented by clinical and budget teams.
• Convert the protocol into a schedule of events, which should be updated with each patient visit throughout the study.
• Review all proposed amendments to understand their impact on the clinical trial and adjust the schedule of events accordingly.
• Update the Clinical Trial Management System or EMR system with the original or updated schedule of events to ensure timely notifications to impacted parties.
• Provide initial clinical interpretation for each protocol and guide the Clinical Educators to ensure consistent interpretation across the organization.
• Escalate all appropriate information to budgets, finance, or Clinical Operations management as necessary.

Requirements

• Extensive oncology knowledge of major cancer types, including disease-related symptom management, standard treatment options, and treatment-related side effect management.
• Knowledge of federal and state regulations and ICH guidelines pertaining to the conduct of clinical trials involving human subjects for Investigator and Sponsor requirements.
• Understanding of the principles, processes, and ethical considerations in clinical trials involving human subjects.
• A general working knowledge of the guidelines, standards, and operating requirements of Institutional Review Boards.
• Experience working in a Clinical Trial Management System.
• Bachelor’s Degree, Master’s Degree preferred.
• At least three years of experience in oncology.
• At least three years of experience in clinical operations.
• At least three years of research experience.
• RN or BSN preferred.
• Research Certification (ACRP or CCRP) preferred.
• Oncology Certification (OCN) preferred.

Qualifications

• Must have extensive oncology knowledge base of all major cancer types including disease related symptom management, standard treatment options, and treatment-related side effect management.
• Must have knowledge of federal and state regulations and ICH guidelines pertaining to the conduct of clinical trials involving human subjects for Investigator and Sponsor requirements.
• Must have knowledge and understanding of the principles, processes, and ethical considerations in clinical trials involving human subjects.
• Must have a general working knowledge of the guidelines, standards and operating requirements of Institutional Review Boards.
• Must have experience working in a Clinical Trial Management System.
• Bachelor’s Degree, Master’s Degree preferred.
• At least three years of experience in oncology.
• At least three years of experience in clinical operations.
• At least three years of research experience.
• RN or BSN preferred.
• Research Certification (ACRP or CCRP) preferred.
• Oncology Certification (OCN) preferred.

Skills

• Strong communication and interpersonal skills.
• Ability to manage multiple tasks and prioritize effectively.
• Proficient in Microsoft Office Suite.
• Excellent analytical and problem-solving skills.
• Strong attention to detail.
• Ability to work independently and as part of a team.

Benefits

We offer a comprehensive benefits package designed to support your physical, mental, and financial well-being. This includes health insurance, retirement plans, paid time off, and more.

Pay

Compensation is determined by several factors, including performance, experience, skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities, may be offered.

Schedule

Details on the work schedule will be provided upon hire.

Benefits

We not only care about the wellbeing of our patients, customers and the communities we serve — we care about you. That’s why we provide our employees with a comprehensive support system for all aspects of Your Care: physical, emotional, financial and social.

Hiring Process

At McKesson, we truly care about the candidate experience and will be with you every step of the way. Ready to take the first step? We’ll guide you along the journey of our hiring process.

Culture and Values

Care, meaning, and belonging — this is the foundation of how we interact with customers, business partners, and each other.

Inclusion & Belonging

Our culture is built around diverse perspectives because everyone’s unique story, experiences, and ideas are valued here.

Early Talent & Internship Opportunities

Students and recent grads: shape the future of health by joining #TeamMcKesson! Apply to one of our internships or full-time opportunities today.