Director of Hematology and Hospital Research Operations

Sarah Cannon Research Institute•Nashville, TN

About The Position

As the Director of Hematology and Hospital Research Operations, you will be responsible for the overall clinical and data operations that involve Hematology, and/or hospital involved trials. The scope includes study operations, clinical operations, program development, and trial management. You are responsible for the development and execution of key strategies that support growth and execution of commitments to pharma and CRO partners. You are responsible for departmental goals, financial performance, quality assurance, oversight, and contracted obligations. The Director must have managerial, leadership skills, and excellent organizational abilities and will work closely with the administrative and physician leadership. Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the world’s leading oncology research organizations conducting community-based clinical trials, focused on advancing therapies for patients over the last three decades. SCRI is a leader in drug development, having conducted more than 850 first-in-human clinical trials and contributed to pivotal research for new cancer therapies approved by the FDA.

Requirements

Knowledge of clinical research process
General knowledge of research regulatory and Quality Assurance guidelines
An Associate’s Degree
At least three years of experience in leadership
At least three years of experience in oncology, specifically blood cancers
At least three years of experience working in research

Nice To Haves

Bachelor Degree is preferred

Responsibilities

Oversees Sites working closely with the Site Manager and Site management team
Problem solves clinical situations along with the Site staff and site leaders as they arise. Engages hospital leadership, if necessary.
Assists in developing and executing Sarah Cannon Research Institute internal and external strategies
Provides operational oversight, leadership and direction in the execution and management of trials
Assesses quality of data and performance of clinical trials through internal mechanisms as well as in partnership with site, monitors and sponsors. Develops action plans to address performance gaps.
Monitors patient accrual rates and implements action plans for accrual issues
Assesses organizational processes associated with trial execution and identifies ways to improve and streamline internal procedures
Meets with hospital administrators and physicians as needed to assess performance of Site as well as to ensure contracted services are being provided by SCRI Site Support and other key departments such as Therapeutic Development, Regulatory, Budgets/Contracts, IT and QA
Keeps executive and management team abreast of issues, progress, and risks related to trial operations
Supports the development, implementation and evaluation of programs to promote recruitment, retention and continuing education of Site research staff
Plans and facilitates meetings and committees to address clinical and operational research issues
Ensures the integrity of data/information, providing recommendations for corrective action when necessary
Attends and participates in all required key meetings including both internal SCRI and at Site
Proactively handles standard of care issues or conflict of interest issues
Assesses and works with Research Sites to ensure compliance
Assists in development and tracking of goals for each Site and reports out at least quarterly
Oversees Site operations specific to hospital impacted studies and hematology research operations
Supports strategic and tactical plans for oncology site growth
Represents company vision to sponsors, site colleagues and affiliated organizations
Communicates to all Research Site's performance standards and expectations
Works with other team members in SCRI Operations department to ensure communication and responsibility are effective among the groups
Collaborates with training and education to ensure continuing education and training to investigators and Research Site staff
Monitors data status through weekly and monthly reporting
Establish accurate and consistent productivity expectations and revise as needed.
Make recommendations regarding staffing requirements to meet departmental needs and achieve maximum productivity.
Develops departmental annual goals and objectives and ensure alignment with organizational mission, vision, and values
Builds and manage strategic internal and external relationships
Monitors expenses and stay within budget
Assists in the creation, development and execution of SOPs, WI and job aids
Meets with leadership team regularly to develop goals and strategies for growth as well as evaluate progress, keep abreast of issues and risks related to research operations