Manager of Study Operations

Sarah Cannon Research Institute•Denver, CO

10d

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. You will 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. You will problem solve clinical situations along with the research staff and the management team as they arise. You will assess the organizational processes associated with trial execution and identifies ways to improve and streamline internal procedures. You will plan, facilitate, and present trial management issues and data status updates at internal and external meetings. You will provide oversight, leadership, and direction in the management and execution of trials. You will assess quality of data and performance of clinical trials and develops action plans to address performance gaps. You will manage, monitor, and operate within allowed budget. You will review of all program billing outcomes and for working with billing staff and Sarah Cannon in addressing issues impacting financial outcomes and patient billing experience. You will work to ensure successful implementation of the EMR and optimization of clinic processes related to OncoEMR implementation to support clinic outcomes and patient experience. You will promote communication and accountability between staff and physicians. You will monitor billing colleagues and services, provides financial reports and completes financial analysis to determine areas for improvement in financial outcomes. You will maintain competency and enhance professional growth and development through continuing education, conferences, and seminars. You will enhance operational effectiveness, emphasizing cost containment without jeopardizing innovation of quality of care. You will oversee all aspects of patient treatment associated with trial execution, including enrollment, patient consent, lab work, data entry, and drug storage/distribution. You will keep the executive team abreast of issues, progress, and risks related to trial operations and the overall clinic and you will meets frequently with all investigators. You will assist in developing and executing internal and external strategies. You are responsible for the recruitment, hiring, training, development, and termination of colleagues, as necessary.

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 identifies 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 develops action plans to address performance gaps.
Manage, monitor, and operate within allowed budget.
Review of all program billing outcomes and for working 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, provides financial reports and completes 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.