JOB SUMMARY

At Houston Methodist, the Quality Assurance Analyst position is responsible for working with specified clinical research teams to conduct ongoing quality assurance reviews of clinical research studies, assess site readiness and develop site specific education and processes to ensure compliance with federal, state laws and Houston Methodist Research Institute (HMRI) requirements.

PRIMARY JOB RESPONSIBILITIES

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

PEOPLE - 20%

Assists institutional investigators and other members of the research team, by providing education and training regarding processes and procedures governing clinical research activities which can be ad-hoc, remote/teleconferences, or face-to-face sessions with the entire research team. (EF)
Partners with specific research teams to identify potential changes and opportunities for improvement, within department and/or study-specific SOPs, policies, training materials, and other documents, as needed. €F
Promotes a positive work environment and contributes to a dynamic, team-focused work unit that actively helps one another to achieve optimal department results. Encourages interdepartmental, as well as institution-wide communication, as it relates to clinical research studies. (EF)
Conducts self in a manner that is congruent with cultural diversity, equity and inclusion principles. Contributes towards improvement of department scores for employee engagement, i.e. peer-to-peer accountability. (EF)

SERVICE - 25%

Educates and mentors research team with interpretation of regulatory requirements (e.g., GCPs), SOP requirements, and other guidance documents, as applicable. (EF)
Assists other Research Protections staff as needed, including IRB, IBC, RSC, and HSC. Provides timely feedback to stakeholders to facilitate swift and efficient process improvement. (EF)
Evaluates site readiness based on HMRI standards prior to start date of a new clinical trial. (EF)

QUALITY/SAFETY - 25%

Conducts feasibility assessments, ongoing quality assurance reviews of clinical research studies, with the goal of assessing site readiness and develop site specific education and processes within specified research teams. (EF)
Coordinates monthly Clinical Research Education Series, the Clinical Research Orientation Program (CROP), and the Annual Clinical Research Conference. (EF)
Meets regularly with the Clinical Trial Manager(s) and Principal Investigators to discuss quality/compliance trends. (EF)
Monitors and evaluates ongoing quality and compliance standards, along with regulatory and clinical trial trends/actions, with regular reports to QA management. Assists with preparation and/or assists during regulatory inspections. (EF)

FINANCE - 15%

Identifies cost saving initiatives within the department and communicates recommendations. (EF)
Utilizes resources with cost effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed. (EF)

GROWTH/INNOVATION - 15%

Evaluates responses to monitoring and audit reports and works with the research team to follow-up with respondents, management, or others, if needed, to ensure resolution. (EF)
Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an on-going basis. (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.

EDUCATION REQUIREMENTS

o Bachelor’s degree in life sciences or related field from an accredited college or university

EXPERIENCE REQUIREMENTS

o Three years Clinical Trial Coordinator or equivalent experience

o Quality Assurance/Regulatory Compliance experience within an FDA regulated industry, preferably devices, diagnostics or pharmaceuticals desirable

o Regulatory audit exposure with US-FDA preferred

CERTIFICATIONS, LICENSES AND REGISTRATIONS REQUIRED

o Society of Clinical Research Associates (SoCRA; CCRP) or Association of Clinical Research Professionals (ACRP; CCRC/CCRA Designations), or equivalent within one year of hire

o Certification in Quality Auditing or Quality Assurance preferred

KNOWLEDGE, SKILLS AND ABILITIES REQUIRED

o Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations

o 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

o Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles

o Excellent working knowledge of FDA regulations and GCP guidelines

o Excellent written and oral communication skills

o Excellent working knowledge of the clinical trial operations

o Ability to develop Quality Assurance strategy and implementation

o Ability to identify and/or resolve quality issues/discrepancies with others in a proactive diplomatic, flexible, and constructive manner

o Ability to work in a team environment with effective leadership skills

SUPPLEMENTAL REQUIREMENTS

Work Attire Yes/No

Uniform No

Scrubs No

Business professional Yes

Other (dept approved) Yes

On-Call* No

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

Travel**

May require travel within Yes

Houston Metropolitan area

May require travel outside No

of Houston Metropolitan area

**Travel specifications may vary by department.

Please note any other special considerations to this job: __________________________

Company Profile:

Houston Methodist Academic Institute was formed to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies and treatments. The Research Institute was created in 2004 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 and clinical trials, the Academic Institute houses over 2,110 credentialed researchers conducting 1,387 ongoing clinical protocols.

Quality Assurance Analyst - Academic Offices of Clinical Trials - Military Veterans

at Houston Methodist

Houston, TX