Senior Quality Assurance Analyst

At Houston Methodist, the Sr 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, serve as a resource and site liaison for Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), and/or Institutional Biosafety Committee (IBC) regulatory needs, as appropriate, and develop site-specific education and processes to ensure compliance with federal, state laws, and Houston Methodist Research Institute (HMRI) policy and procedure requirements. In addition to performing the duties as a Quality Assurance Analyst, this position serves as a mentor and subject matter expert to study teams and QA team on Good Clinical Practice in Clinical Research, QA practices, HMRI policy and procedures related to clinical research.

FLSA STATUS
Exempt

QUALIFICATIONS

EDUCATION

• Bachelor’s degree in life sciences or related field from an accredited college or university
• Master’s degree in business or life sciences or related field preferred

EXPERIENCE

• Five years clinical research or equivalent experience in which three years are in Quality Assurance or Regulatory Compliance experience within an FDA regulated industry, preferably devices, diagnostics, or pharmaceuticals desirable
• Training experience in a clinical research setting
• Regulatory audit exposure with US-FDA preferred

LICENSES AND CERTIFICATIONS
Required

• Must have one of the following certifications: CCRP - Certified Clinical Research Professional (SOCRA) or CCRC - Certified Clinical Research Coordinator (ACRP) or CCRA - Certified Clinical Research Associate (ACRP) or ACRP-CP - Clinical Research Professional (ACRP)

SKILLS AND ABILITIES

• Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through ongoing 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 guidelines
• Excellent working knowledge of the clinical trial operations
• 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

ESSENTIAL FUNCTIONS

PEOPLE ESSENTIAL FUNCTIONS

• Facilitates open, professional (verbal, nonverbal, written) communication which includes active listening and teaching, to achieve mutual understanding, role modeling by example. Communication to promote both work efforts and problem resolution is clear, providing the highest quality service during every customer and patient encounter, as it relates to clinical research studies.
• Provides higher-level support to 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.
• Serves as a subject matter expert and regulatory resource for department and institution as well as investigators and research staff regarding Institutional Review Board (IRB) and/or Institutional Animal Care and Use committees, current institutional policies, and state and federal laws related to research; provides solutions to study start-up and regulatory management.
• Teaches, orients and precepts, as appropriate, newly hired analysts. Uses peer-to-peer accountability towards improvement of department score for employee engagement.

SERVICE ESSENTIAL FUNCTIONS

• Assists in identifying educational needs and creates/implements training courses or materials to assist in compliant research coordination and management.
• Assists Research Protections staff and HMRI administration, as needed, with pre-clinical and clinical research areas of need, including Research Credentialing, IRB, Institutional Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC), and Hazardous Substance Committee (HSC), as appropriate. Provides timely feedback to stakeholders to facilitate swift and efficient process improvement.
• Evaluates site readiness based on HMRI standards prior to start date of a new clinical trial.

QUALITY/SAFETY ESSENTIAL FUNCTIONS

• Performs and monitors feasibility assessments, ongoing quality assurance reviews of with pre-clinical and clinical research studies, with the goal of assessing site readiness and develop site-specific education and processes within specified research teams. May assess reviews of lower-level analysts.
• 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.
• Initiates goals and creates targets for Monitoring Assessment plans (MAPS). Assumes primary responsibility for implementing plan, organizing data, and reporting results to leadership.
• Utilizes sound judgement, using an analytical approach. Ensures implementation and teaching of department-based initiatives and standards of practice. Identifies trends and opportunities for corrective action and process improvement, providing recommendations.

FINANCE ESSENTIAL FUNCTIONS

• Initiates cost saving ideas within the department and communicates recommendations to management.
• 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.

GROWTH/INNOVATION ESSENTIAL FUNCTIONS

• Independently evaluates responses to monitoring and audit reports; partners with the research team to follow up with respondents, management, or others, if needed, to ensure resolution.
• Identifies and presents areas for innovation, efficiency, and improvement for department projects. Participates in one or more department committees or subcommittees and facilitates the accomplishment of the goals of the committee or subcommittee.
• 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 ongoing basis.

SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE

• Uniform: No
• Scrubs: No
• Business professional: Yes
• Other (department approved): Yes

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 Yes
• May require travel outside Houston Metropolitan area No

QUALIFICATIONS

EDUCATION

• Bachelor’s degree in life sciences or related field from an accredited college or university
• Master’s degree in business or life sciences or related field preferred

EXPERIENCE

• Five years clinical research or equivalent experience in which three years are in Quality Assurance or Regulatory Compliance experience within an FDA regulated industry, preferably devices, diagnostics, or pharmaceuticals desirable
• Training experience in a clinical research setting
• Regulatory audit exposure with US-FDA preferred

LICENSES AND CERTIFICATIONS
Required

• Must have one of the following certifications: CCRP - Certified Clinical Research Professional (SOCRA) or CCRC - Certified Clinical Research Coordinator (ACRP) or CCRA - Certified Clinical Research Associate (ACRP) or ACRP-CP - Clinical Research Professional (ACRP)