Clinical Research Manager Jobs

About The Position

Requirements

• Bachelor's Degree of Science other health related field.
• Minimum 5 years in Clinical Research Required
• Minimum 2 years in supervisory/management experience Required
• 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.

Nice To Haves

• Advanced degree in Science or other health related field.
• Research certification Preferred and Expectation of achieving research certification within 1 Year Required

Responsibilities

• 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
• 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
• 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
• 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
• 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.

Benefits

• support to do more meaningful work—and enjoy a more rewarding life