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Work Shift

Job Summary:

The Manager of the WellStar Research Institute is responsible for operations of the WellStar Research Institute including staff oversight and administration of HR functions. Responsible for management of clinical trials from start-up through close-out. Serves as operational contact for sponsors, physicians, and other customers. Ensures appropriate staff training and development. Coordinates departmental functions with operations of other WellStar departments. Implements standards of practice, interprets system and departmental policies and procedures, and ensures quality patient care. Ensures appropriate staff training and adherence to policies and regulations surrounding human research protections.

Core Responsibilities and Essential Functions:

Staff Management/Leadership
* Coordinate internal education for development of staff
* Evaluate employee performance using approved Performance Management model in accordance with Human Resources Policy and Practice.
* Provide day to day oversight of research staff
* Provide appropriate levels of staffing and manage schedule of personnel
* Ensure appropriate orientation, education, credentialing, licensing, and continuing professional development for personnel, including study-specific training, GCP training and IATA certification
* Use behavioral interviewing techniques to hire and accept for transfer candidates to fill vacancies in the department.
* Use independent judgment to reward exemplary performance and address substandard performance in accordance with the employee disciplinary policy.
* Coordinate and monitor Trust survey completion and appropriate action planning sessions and progress
Business Development
* Assist physicians with recruitment of clinical trials
* Serve as the central operational contact for sponsors, physicians, and system departments
* Develop and maintain collateral material to support research services (printed and on WEB page)
* Monitor key trends in the industry
* Participate in clinical research related and organizational policy formulation
* Contributes to the strategic planning process by leading operations to fulfill the mission, vision and strategic goals
Study Management
* Coordinate review of all protocols for feasibility with affected departments and primary investigators
* Coordinate clinical trial related procedures with other healthcare disciplines
* Evaluate the quality and appropriateness of clinical trials, research projects and research related procedures
* Assist with study building and management in the CTMS system
* Coordinate the study approval process with departmental and system leaders
* Monitor progress of research studies from start-up through close-out and identify and resolve issues
* Operationalize feasible clinical studies across multiple WHS facilities
* Oversee investigational drug and device accountability and tracking
* Coordinate sponsor monitoring visits and audits, and resolution of issues
Finance
* Assist with annual research departmental budget development and management
* Participate in research study budget development, including time and effort analysis
* Monitor the appropriate routing of research charges in the Epic EMR system
* Assist with monthly departmental billing
* Collaborate with Revenue Management to ensure that WRI processes lead to appropriate research billing
Regulatory/Compliance
* Ensure FDA and other governmental agency compliance with all FDA, Post Market and IIR trials
* Work with compliance department on an ongoing basis
* Assist with evaluating and communicating appropriate and compliant research billing, including CIB
* Assist with appropriate routing of new research projects
* Coordinate and support FDA and other governmental research audits
* Provide support and assistance for additional research initiatives
Performs other duties as assigned
Complies with all WellStar Health System policies, standards of work, and code of conduct.

Required Minimum Education:

BSN Required

MSN Preferred

Required Minimum License(s) and Certification(s):

All certifications are required upon hire unless otherwise stated.

Additional License(s) and Certification(s):

Research certification Preferred and
Expectation of achieving research certification within 1 Year Required

Required Minimum Experience:

Minimum 5 years in Clinical Research Required and
Minimum 2 years in supervisory/management experience Required

Required Minimum Skills:

Functions independently and proactively with strong critical thinking, analytical, and communication skills.
Effectively prioritizes tasks and follows-up to ensure completion of tasks in a compliant and timely manner.
Effectively applies problem solving, negotiation, and continuous quality improvement methods in daily operations.
Works collaboratively and professionally with all customers.
Provides superior customer service to effectively meet the needs of internal and external customers.
Demonstrates the characteristics of an effective team member.
Actively participates in staff orientation, continuing education, and mentoring.
Committed to promoting a culture that values compliance to the WHS Code of Conduct.

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