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:

• ◊ Bachelor's degree or higher from an accredited school of nursing

• ◊ Medical degree

• ◊ 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

LICENSES AND CERTIFICATIONS - REQUIRED

• Six Sigma Green Belt Certification (IASSC, ASQ, CSSC) OR

• CPHQ - Certified Professional in Healthcare Quality (NAHQ) OR

• CHRC - Certified in Healthcare Research Compliance (HCCA) OR

• CCRP - Certified Clinical Research Professional (SOCRA) OR

• PMP - Certified Project Management Professional (PMI) OR

• Specialty certification in clinical discipline

LICENSES AND CERTIFICATIONS - PREFERRED

• BLS - Basic Life Support (AHA)

KNOWLEDGE, SKILLS, AND ABILITIES

• 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

• Uniform No

• Scrubs No

• Business professional Yes

• Other (department approved) No

ON-CALL*

*Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.

• On Call* No

TRAVEL

Travel specifications may vary by department

• May require travel within the Houston Metropolitan area No

• May require travel outside Houston Metropolitan area No

Company Profile:

Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care.

Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 trainees in residence for medical, nursing, allied health and research education programs.

Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.

Houston Methodist is an equal opportunity employer inclusive of women, minorities, disabled persons and veterans.

Equal Employment Opportunity

Houston Methodist is an Equal Opportunity Employer.

Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law. VEVRAA Federal Contractor – priority referral Protected Veterans requested.

Houston Methodist is an Equal Opportunity Employer.

Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law. VEVRAA Federal Contractor – priority referral Protected Veterans requested.