Manager of Research EMR Operations

About the role

As the Manager of Research EMR Operations at Sarah Cannon Research Institute (SCRI), you will play a crucial role in advancing oncology treatments and improving outcomes for cancer patients. Reporting to the Scientific Director or Program Managers, you will manage a team of EMR Analysts to ensure productivity, quality, and timeline metrics are met. Your responsibilities include managing protocol builds, reviewing amendments, creating schedules of events, and providing clinical interpretation for protocols.

Responsibilities

• Manage the team performing clinical interpretation of protocols and transferring this interpretation into detailed schedules of events.
• 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, serving as a single point of contact for the team.
• 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.
• 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 the clinical and budget teams.
• Convert the protocol into a schedule of events, capturing each patient visit throughout the study's lifecycle.
• 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 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.
• 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.
• 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

• Bachelor’s Degree, Master’s Degree is preferred.

Benefits

We care about the well-being of the patients and communities we serve, and that starts with caring for our people. At Sarah Cannon Research Institute, we offer a comprehensive Total Rewards package that includes benefits to support physical, mental, and financial well-being. Our benefits include:

• Comprehensive benefits to support physical, mental, and financial well-being.
• Competitive compensation package based on performance, experience, and skills.
• Annual bonuses or long-term incentive opportunities.

Pay

The compensation for this position is determined by several factors, including performance, experience, and 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 schedule will be provided upon employment.

Skills

Skills required for this role include:

• Extensive oncology knowledge base.
• Knowledge of federal and state regulations and ICH guidelines.
• Understanding of clinical trial ethics and IRB guidelines.
• Experience in a Clinical Trial Management System.
• Strong communication and interpersonal skills.
• Ability to manage multiple tasks and meet deadlines.
• Attention to detail and ability to work independently.

Benefits

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.