Job description

At Houston Methodist, the Quality Assurance Analyst for the Academic Offices of Clinical Trails 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 The Methodist Hospital Research Institute requirements.

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. This training can be ad-hoc, remote/teleconferences, or face-to-face sessions with the entire research team.
• 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.
• Encourages interdepartmental, as well as institution wide communication, as it relates to clinical research studies.

SERVICE - 20%

• Participates in HM projects if applicable.
• Assists other Research Protections staff as needed, including IRB, IBC, RSC, and HSC.

QUALITY/SAFETY - 45%

• Functions within specified research teams to conduct feasibility assessments, ongoing quality assurance reviews of clinical research studies, with the goal of assessing site readiness and develop site specific education and processes.
• Assists with preparation and/or assists during regulatory inspections.
• Educates and mentors research team with interpretation of regulatory requirements (e.g., GCPs), SOP requirements, and other guidance documents, as applicable.
• Meets regularly with the Clinical Trial Manager(s) and Principal Investigators to discuss quality/compliance trends.
• Evaluates site readiness based on TMHRI standards prior to start date of a new clinical trial.
• Monitors and evaluates ongoing quality and compliance standanrds, along with regulatory and clinical trial trends/actions, with regular reports to QA management.
• Provides timely feedback to stakeholders to facilitate swift and efficient process improvement.

FINANCE - 5%

• Appropriately utilizes department resources such as time and equipment.

GROWTH/INNOVATION - 10%

• 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.
• Coordinates monthly Clinical Research Education Series, the Clinical Research Orientation Program (CROP), and the Annual Clinical Research Conference.

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

• Bachelor's degree in life sciences or related field from an accredited college or university required.

EXPERIENCE REQUIREMENTS

• Minimum of 3 years Clinical Trial Coordinator or equivalent experience required.
• Quality Assurance/Regulatory Compliance experience within an FDA regulated industry, preferably devices, diagnostics or pharmaceuticals desirable.
• Regulatory audit exposure with US-FDA is desirable.

Job Type: Full-time

Pay: $57,491.20 - $74,734.40 per year

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Houston, TX 77030: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• clinical trials and/or equivalent: 3 years (Required)

Work Location: In person

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