Manager of Research EMR Operations

McKesson•Nashville, TN

About The Position

As the Manager of Research EMR Operations, you are responsible for managing the team performing clinical interpretation of protocols and transferring this interpretation into the detailed schedule of events. You will manage the team of EMR Analysts to ensure productivity, quality, and timeline metrics are met. You will develop relationships between departments to ensure protocol impacts are communicated out. You will review protocol builds for accuracy, thoroughness, compliance, and sufficiency. You will manage the amendment intake process in which the team acts as a single point of contact. You will serve as a scientific and clinical expert in the interpretation of clinical trial protocols. You will work directly with the Scientific Director and/or Physicians and/or Program Managers to validate proper interpretation of the protocol. You will prepare for the Sarah Cannon Clinical Operations Protocol Review Committee by evaluating and assessing presenting protocols in advance to determine complexity, identify risks associated with a trial, and operational and implementation challenges. You will create and update the protocol-specific Clinical Operation worksheet with pertinent study information to use as a study lead tool for Sarah Cannon Clinical Operations and applicable sites. You will attend the Sarah Cannon Clinical Operations Protocol Review Committee to capture any details presented by the clinical and budget teams. You will convert the protocol into a schedule of events which should be completed with each patient visit during the life of the study. You will review all proposed amendments to understand the impact to the clinical trial. Adjust the schedule of events to capture any adjustments specified by trial amendments. You will update the Clinical Trial Management System or EMR system with the original or updated schedule of events to ensure timely notification to impacted parties. You will provide initial clinical interpretation for each protocol and guide the Clinical Educators to ensure consistent interpretation across the organization. You will escalate all appropriate information to budgets, finance, or Clinical Operations management as deemed necessary.

Requirements

Extensive oncology knowledge base of all 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.
Knowledge and understanding of the principles, processes, and ethical considerations in clinical trials involving human subjects.
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.
At least three years of experience in oncology.
At least three years of experience in clinical operations.
At least three years of research experience.

Nice To Haves

Master’s Degree is preferred.
RN or BSN is preferred.
Research Certification (ACRP or CCRP) preferred.
Oncology Certification (OCN) preferred.

Responsibilities

Manage the team performing clinical interpretation of protocols and transfers this interpretation into the detailed schedule of events.
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 in which the team acts as a single point of contact.
Serve as scientific and clinical expert in the interpretation of clinical trial protocols.
Work directly with Scientific Director and/or Physicians and/or Program Managers to validate proper interpretation of the protocol.
Prepare for the Sarah Cannon Clinical Operations Protocol Review Committee by evaluating and assessing presenting protocols in advance to determine complexity, identify risks associated with a trial and operational and implementation challenges.
Create and update the protocol specific Clinical Operation worksheet with pertinent study information to use as a study lead tool for Sarah Cannon Clinical Operations and applicable sites.
Attend the Sarah Cannon Clinical Operations Protocol Review Committee to capture any details presented by the clinical and budget teams.
Convert the protocol into a schedule of events which should be completed with each patient visit during the life of the study.
Review all proposed amendments to understand the impact to the clinical trial.
Adjust the schedule of events to capture any adjustments specified by trial amendments.
Update the Clinical Trial Management System or EMR system with the original or updated schedule of events to ensure timely notification to impacted parties.
Provide initial clinical interpretation for each protocol and guide the Clinical Educators to insure consistent interpretation across the organization.
Escalate all appropriate information to budgets, finance, or Clinical Operations management as deemed necessary.