Manager Clinical Research - Quality Assurance

At Houston Methodist, the Manager Clinical Research Quality Assurance (CRQA) position is responsible for the development, implementation and management of a Quality Management Program for the institution's clinical research operations and activities. The Manager, CRQA position will establish and execute quality plans, policies and quality system elements related to GCP (Good Clinical Practice) activities. This position will support the design, implementation and maintenance of QA and compliance programs including, but not limited to an SOP system, CAPAs (Corrective and Preventive Actions), Clinical Research Education and work closely with Clinical Operations and research teams. The Manager, CRQA position will establish, maintain, and ensure effectiveness of Quality Management System programs and documentation to assure compliance in a GCP regulatory environment and provide GCP guidance in Quality related areas. All research studies, independent of focus or risk category, being conducted at Houston Methodist or by a Houston Methodist employee, are subject to HM Quality Assurance Program's oversight, as well as auditing and monitoring by Houston Methodist Research Institute (HMRI) or its agents.

The manager position responsibilities include managing the daily work activities of the work unit/department staff, ensuring quality, productivity, functional excellence and efficiency while assisting management in accomplishing strategic and operational objectives. In addition, this position provides guidance to staff and is responsible for staffing, budget compliance, contributing to staffing decisions such as hiring and terminating employment, coaching and counseling employees on work related performance, and assisting in the development and implementation of policies and procedures to ensure a safe and effective work environment. This position also implements training, monitoring and operations initiatives that secure compliance with ethical and legal business practices and accreditation/regulatory/ government regulations.

PEOPLE ESSENTIAL FUNCTIONS
Performs management responsibilities of selection, scheduling, supervision, retention, and evaluation of employees in the department. Provides development and mentoring of staff. Meets or exceeds threshold goal for department turnover. Develops direct reports to perform these same functions.
Provides fair and consistent leadership and communication to maintain a competent and engaged employee group by conducting regular department meetings to review policies and procedures and operational matters, rounding on all employees, completing performance appraisals, conducting new hire feedback sessions, coaching/corrective counseling, and providing recognition/commendations to achieve desired outcomes. Provides timely guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task or solve a problem.
Facilitates and promotes effective team dynamics and teambuilding strategies within and between departments; participates and/or leads and facilitates department process improvements as needed.
Meets or exceeds threshold goal for department and/or system metrics on employee engagement indicators.
Develops high quality presentation materials that clearly outline performance improvement initiatives and lay out a logical and compelling storyline that drives toward a recommendation or set of strategic consideration.

SERVICE ESSENTIAL FUNCTIONS
Plans and organizes day-to-day department operations, schedule and activities. Sets priorities and functional standards, giving direction to staff as necessary to ensure the best possible delivery of service and high customer/patient satisfaction.
Drives department service standards and activities to impact department and/or system score for patient/customer-based satisfaction, through role modeling and fostering accountability. Serves and actively participates on various entity committees as a voice for the department.

QUALITY/SAFETY ESSENTIAL FUNCTIONS
Ensures a safe and effective working environment; monitors and/or revises the department safety plan and/or any specific accreditation/regulatory required safety guidelines, including infection control principles. Monitors and confirms staff maintain their required credentials that demonstrate competency per accrediting agency or department guidelines as applicable.
Uses and optimizes information systems to enhance operations; supports entity-specific performance improvement and data management/analysis functions.
Employs a proactive approach in the optimization of safe outcomes by monitoring and improving the department workflow, using peer-to-peer accountability, reporting accidents, near misses, and/or adverse events immediately per department protocol and identifying solutions via collaboration. Adopts lean principles in driving process improvements. Role models situational awareness, using teachable moments to improve safety.
Monitors self and employee compliance with policies, procedures, and System HR Standards of Practice and performs associated actions upon non-compliance (i.e., focal point review requirements, disaster plan, in-services, influenza immunization, wage and hour, standard hours, timely termination submission, timely timecard approval, etc.).
Identifies quality improvement opportunities through analysis of facility and external benchmark data. Appropriately delegates and manages outcome for project assignments to qualified staff. Supports facility external benchmarking initiatives.

FINANCE ESSENTIAL FUNCTIONS
Assists in the development of department budget and ensures that the department operates in a cost effective manner. Manages/audits department expenses within approved budget parameters, ensuring that the department meets the budgeted/flex revenue and/or expense targets on a monthly and annual basis. Develops staffing plans and schedules to meet department/patient needs that reflect understanding of the importance of cost-effectiveness.
Implements department strategies to achieve financial target and staffing needs, developing others to do the same, through optimizing productivity, supply/resource efficiency, minimizing incidental overtime and overtime percentage, and other areas according to department specifications.
Identifies strategies and opportunities for financial efficiency and improvement of operations.

GROWTH/INNOVATION ESSENTIAL FUNCTIONS

Identifies and implements innovative solutions for practice or workflow changes to improve department operations or other department-specific measures by leading unit projects and/or other department/system directed/shared governance activities. Supports change initiatives, maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusts effectively to work within new work structures, processes, requirements or cultures.
Proactively evaluates processes; recommends and implements action plan(s) for change; follows through to ensure effective, sustainable change. Participates in the development and implementation of new procedures and the review and revision of existing procedures.
Identifies opportunities and takes action to build strategic relationships between one's area and other areas, teams, departments, and units to achieve business goals.
Seeks opportunities to identify developmental needs of self and staff and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates My Development Plan (MDP) on an on-going basis. Conducts conversations with staff on their development.
Drives and participates in the process of innovation to drive teams to new avenues of growth.

This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.
EDUCATION
Must have one of the following:
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Bachelor's degree or higher from an accredited school of nursing
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Medical degree
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Master's degree in science or related healthcare field

WORK EXPERIENCE
Seven years of clinical research experience in clinical trials, regulatory compliance or quality assurance, to include two years of supervisory experience, for internals, 7 years of clinical research experience in clinical trials, regulatory compliance or quality assurance with one year HM performance that demonstrates leadership responsibility

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