Manager of Study Operations

Sarah Cannon Research Institute•Denver, CO

11d

About The Position

The Manager of Study Operations is responsible for the overall research data operations in the Phase I solid tumor Drug Development Unit and the Colorado Blood Cancer Institute research program. This role involves overseeing clinical trial-related activities performed by research staff to ensure completeness, accuracy, and adherence to federal and state guidelines. The Manager will problem-solve clinical situations with the research staff and management team, assess and improve organizational processes for trial execution, and plan, facilitate, and present trial management issues and data status updates. Key responsibilities include providing oversight, leadership, and direction in trial management, assessing data quality and trial performance, developing action plans for performance gaps, and managing within budget. The role also involves reviewing program billing outcomes, collaborating with billing staff and Sarah Cannon to address financial issues, and ensuring successful implementation and optimization of the EMR (OncoEMR) to support clinic outcomes and patient experience. Additionally, the Manager will promote communication and accountability between staff and physicians, monitor billing colleagues and services, provide financial reports, and complete financial analysis. Maintaining competency through continuing education and enhancing operational effectiveness with an emphasis on cost containment are also crucial. The Manager will oversee all aspects of patient treatment associated with trial execution, including enrollment, consent, lab work, data entry, and drug handling, while keeping the executive team informed of progress and risks, and meeting frequently with investigators. The role also includes assisting in developing and executing internal and external strategies and is responsible for recruitment, hiring, training, development, and termination of colleagues as needed.

Requirements

A Bachelor’s Degree is required
Knowledge of FDA guidelines and GCP.
Must be able to read, understand and comply with research protocols.
Experience using clinical trial databases, electronic data capture, MS Access and MS Excel.
At least three years of experience in an oncology setting

Nice To Haves

At least one year of experience supervising or managing others
At least one year of experience in blood cancer/Bone Marrow Transplant (BMT) Research
Certification (ACRP or CCRP) preferred

Responsibilities

Oversee clinical trial-related activities completed/performed by the research staff to ensure completeness and accuracy as well as adherence to federal and state guidelines.
Problem solve clinical situations along with the research staff and the management team as they arise.
Assess the organizational processes associated with trial execution and identify ways to improve and streamline internal procedures.
Plan, facilitate, and present trial management issues and data status updates at internal and external meetings.
Provide oversight, leadership, and direction in the management and execution of trials.
Assess quality of data and performance of clinical trials and develop action plans to address performance gaps.
Manage, monitor, and operate within allowed budget.
Review of all program billing outcomes and work with billing staff and Sarah Cannon in addressing issues impacting financial outcomes and patient billing experience.
Work to ensure successful implementation of the EMR and optimization of clinic processes related to OncoEMR implementation to support clinic outcomes and patient experience.
Promote communication and accountability between staff and physicians.
Monitor billing colleagues and services, provide financial reports and complete financial analysis to determine areas for improvement in financial outcomes.
Maintain competency and enhance professional growth and development through continuing education, conferences, and seminars.
Enhance operational effectiveness, emphasizing cost containment without jeopardizing innovation of quality of care.
Oversee all aspects of patient treatment associated with trial execution, including enrollment, patient consent, lab work, data entry, and drug storage/distribution.
Keep the executive team abreast of issues, progress, and risks related to trial operations and the overall clinic.
Meet frequently with all investigators.
Assist in developing and executing internal and external strategies.
Responsible for the recruitment, hiring, training, development, and termination of colleagues, as necessary.