Houston Methodist Academic Institute
6670 Bertner Ave
Houston, TX 77030
Category: Academic Institute
Job Type: Full-Time
Posted Date: May 25, 2021
At Houston Methodist, the ACM Quality Assurance Analyst is responsible for working wtih 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.
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. 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.
- Bachelor's degree in life sciences or related field from an accredited college or university required.
- 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.
CERTIFICATIONS, LICENSES AND REGISTRATIONS REQUIRED
- A certification in Quality Auditing or Quality Assurance is desirable.
- Society of Clinical Research Associates (SoCRA; CCRP) or Association of Clinical Research Professionals (ACRP; CCRC/CCRA Designations), or equivalent required within one year of hire.
KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
Please add additional knowledge, skills and abilities required to perform the essential functions.
- 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 with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
- Excellent working knowledge of FDA regulations and GCP guideline.
- Excellent written and oral communication skills.
- Excellent working knowledge of the clinical trial operations.
- Ability to develop Quality Assurance strategy and implementation.
- Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.
- Ability to work in a team environment with effective leadership skills.
Please indicate the requirements of the job by selecting the appropriate response.
|Other (dept approved) ||No|
|On-Call* ||No (for Non-Exempt or Exempt jobs)|
*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: __________________________
A cornerstone of Houston Methodist's strategic vision as a source for leading care, Houston Methodist Academic Institute conducts ground breaking translational and clinical research to provide the best care to patients in our community and around the world. At Houston Methodist, fostering innovations with the potential for clinical application is at the very heart of what we do. Our interdisciplinary teams of clinicians and researchers are committed to streamlining the process of translating discoveries into treatments and cures for our patients.