Director, Clinical Research Operations

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Work Shift

Day (United States of America)

Job Summary:

The Director of the Wellstar Research Institute is responsible for the clinical operations of multiple facilities throughout the hospital system. This is an essential leadership role responsible for direct oversight of staff, ensuring clinical excellence and best practices, and is responsible for management of clinical trials from start-up through close-out. This includes effective execution of clinical trials including patient recruitment, clinical activities, serving as operational contact for sponsors, physicians, and other internal and external customers and stakeholders. Ensures appropriate staff training and development. Coordinates departmental functions with operations of other Wellstar departments. Responsible for process improvements and implementation of tools and work flows to enhance efficiencies, productivity, and conflict resolution of clinical issues. 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. Responsible for site assessments and program development for new research service lines and research sites in conjunction with the AVP, Research Administration. Works with AVP to review and approve research studies at Wellstar Medical College of Georgia Hospital (WMCGH). In conjunction with AVP, Research Administration, will be responsible for ensuring effective clinical operations at WMCGH and collaborating with WMCGH departments impacted by research to support operationalizing trials.

Core Responsibilities and Essential Functions:

Staff Management/Leadership
* Develop or 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
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
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
*Research program development for service lines and facilities new to research.
*Collaborate with AVP, Research Administration to execute and implement research infrastructure at additional facilities.
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
Participates in meetings, serves on committees and represents the Institute in community outreach efforts as appropriate.
Performs other duties as assigned
Complies with all Wellstar Health System policies, standards of work, and code of conduct.

Required Minimum Education:

• Bachelors Nursing or Masters Nursing-Preferred or Masters Health Administration-Preferred

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

All certifications are required upon hire unless otherwise stated.

• RN - Reg Nurse (Single State) or RN-COMPACT - RN - Multi-state Compact
• CCRP - Cert Clinical Research Prof within 1 Year or CCRC - Cert Clinical Research Coord within 1 Year or CIP - Certified IRB Professional-Preferred

Additional License(s) and Certification(s):

Required Minimum Experience:

Minimum 7 years Clinical Research Site Management Required and
Minimum 7 years Nursing Required

Required Minimum Skills:

Functions independently and proactively with strong critical thinking, analytical, and communication skills. High
Effectively prioritizes tasks and follows-up to ensure completion of tasks in a compliant and timely manner. High
Effectively applies problem solving, negotiation, and continuous quality improvement methods in daily operations. High
Works collaboratively and professionally with all customers. High
Provides superior customer service to effectively meet the needs of internal and external customers. High
Committed to promoting a culture that values compliance to the WHS Code of Conduct. High
MS Office Suite. Medium
Clinical terminology. High
Proficient computer skills; High
Knowledge and understanding of the management and implementation of clinical/translational research operations. High
Advanced knowledge and understanding of policies, procedures, and regulations governing human subject's research, and stipulations of sponsor contracts or requirements and incorporates them in the conduct of research. High
Advanced knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH, and HIPAA regulations. High
Knowledge of the policies and procedures and requirements of internal departments involved in the approval of research (IRB, grants, contracts, finance, etc.) and the ability to proficiently and compliantly maneuver though the approval processes and assure compliance throughout the research process. Medium
Works collaboratively with other staff and departments to complete research protocols. High
Ability to build credible relationships internally and externally. High
Possesses ability to communicate, both verbally and in writing, clearly and concisely. High
Uses effective presentation and meeting techniques. Medium
Strong analytical and problem-solving skills. High
Excellent interpersonal and organizational skills, good oral and written communication skills. High
Able to obtain training or train others to safely and accurately perform or assess required protocol procedures. High
Exemplary leadership and interpersonal skills, with the ability to build effective liaisons and partnerships Medium
Knowledge of clinical trials, research and general medicine. High
Must be committed to continuous improvement, accountability and customer service. High
Experience working with research-related committees, e.g., IRB, IACUC, radiation safety Medium
Highly developed creative and managerial skills High

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