Clinical Research Quality Assurance Manager

Overview

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. 

Houston Methodist Standard

Refer to departmental "Scope of Service" and "Provision of Care" plans, as applicable, for description of primary age groups and populations served by this job for the respective HM entity.

• Provide personalized care and service by consistently demonstrating our I CARE values:
  • INTEGRITY: We are honest and ethical in all we say and do.
  • COMPASSION: We embrace the whole person including emotional, ethical, physical, and spiritual needs.
  • ACCOUNTABILITY: We hold ourselves accountable for all our actions.
  • RESPECT: We treat every individual as a person of worth, dignity, and value.
  • EXCELLENCE: We strive to be the best at what we do and a model for others to emulate.
• Focuses on patient/customer safety
• Delivers personalized service using HM Service Standards
• Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET, Managing Up, Key Words)
• Intentionally rounds with patients/customers to ensure their needs are being met
• Involves patients (customers) in shift/handoff reports by enabling their participation in their plan of care as applicable to the given job
• Displays cultural humility, diversity, equity and inclusion principles
• Actively supports the organization vision, fulfills the mission and abides by the I CARE values

 

Responsibilities

Job responsibilities labeled EF capture those duties that are essential functions of the job.

 

PEOPLE - 30%

Performs management responsibilities of selection, scheduling, supervision, retention, and evaluation of employees in the department. Provides development and mentoring of Meets or exceeds threshold goal for department turnover. Develops direct reports to perform these same functions. (EF)

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. (EF)

Facilitates and promotes effective team dynamics and teambuilding strategies within and between departments; participates and/or leads and facilitates department process improvements as needed. (EF)

Meets or exceeds threshold goal for department and/or system metrics on employee engagement indicators. (EF)

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. (EF) 

 

SERVICE - 20%

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. (EF)

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. (EF)   

 

 

QUALITY/SAFETY - 30%

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.  (EF)

Uses and optimizes information systems to enhance operations; supports entity-specific performance improvement and data management/analysis functions. (EF)

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.  (EF)

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.). (EF)

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. (EF)

 

FINANCE - 10%

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. (EF)

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. (EF)

Identifies strategies and opportunities for financial efficiency and improvement of operations. (EF)

 

GROWTH/INNOVATION - 10%

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. (EF)

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. (EF)

Identifies opportunities and takes action to build strategic relationships between one's area and other areas, teams, departments, and units to achieve business goals. (EF)

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. (EF)

Drives and participates in the process of innovation to drive teams to new avenues of growth. (EF) 

 

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.

 

Qualifications

Must have one of the following:

• Bachelor's degree or higher from an accredited school of nursing
• Medical degree
• Master's degree in science or related healthcare field.

Seven years of Clinical Research experience in clinical trials, regulatory compliance or Quality Assurance, to include two years of supervisory experience

License/Certification

Must have one of the following:

• Six Sigma certification
• Certified Professional in Healthcare Quality (CPHQ)
• Certified in Healthcare Research Compliance (CHRC)
• Certified Clinical Research Professional (CCRP)
• Project Management Professional (PMP) certification, or
• Specialty certification in clinical discipline
• American Heart Association Basic Life Support (BLS) preferred

KSA/ Supplemental Data

• Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
• Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
• Ability to effectively communicate through a variety of channels with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles; engages the recipient(s) and helps them understand and retain the message
• Demonstrates the ability to interact with others in a way that gives them confidence in one's intentions and those of the organization
• Ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans; modifying one's own behavior to accommodate tasks, situations and individuals involved
• Demonstrates leadership qualities and critical thinking through self-direction initiative and effective interpersonal skills and oral/written communication skills
• Ability to identify and understand issues, problems and opportunities, comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints and probable consequences
• Ability to work effectively in a fast paced environment
• Demonstrates flexibility and adaptability in the workplace
• Demonstrates experience in understanding and executing performance improvement concepts and activities
• Ability to manage and manipulate large scale longitudinal data sets covering multiple populations
• Advanced skill in use of spreadsheet and relational database software
• Strong presentation skills and ability to facilitate work teams.
• Skill in use of clinical and operational outcomes and comparative performance benchmark databases

 

SUPPLEMENTAL REQUIREMENTS

Work Attire                             Yes/No

Uniform                                   No

Scrubs                                    No      

Business professional           Yes

Other (dept approved)          No

 

On-Call*                                 No

*Note that employees may be required to be on-call during emergencies (i.e., Disaster, Severe Weather Event, etc.) regardless of selection above            

Travel**                                

May require travel within        No

Houston Metropolitan area

 

May require travel outside                  No

of Houston Metropolitan area                     

 

 

**Travel specifications may vary by department.

 

 

 

Company Profile

Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies, and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 284 principal investigators and has more than 570 ongoing clinical trials.

Employment Type: FULL_TIME