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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Working within the Office of Research Protections (ORP) at Houston Methodist Research Institute (HMRI), the QA Analyst works together with assigned Clinical Research teams to promote a prospective, integrated QA program designed to attain excellence in the conduct of Human Subject Research and compliance with federal, state laws and HMRI policy.
Duties and Responsibilities are cross-referenced to the hospital’s Pillars of Excellence and will be transferred to the Performance Evaluation.
Assures timely communication and assessment of clinical trial readiness and QA needs through routine meetings with Principal Investigators and Clinical Trial Managers;
Integrates the QA Program and Analysts into specified research teams. Promotes the QA mission by identifying issues that may prevent acceptance into other departments, addressing specific concerns of the research teams, and making the research teams an integral part of the QA Program.
Assures appropriate use of departmental resources;
Identifies processes that improve efficiency and reach of the QA Program.
Assures quality via study start up and first subject reviews for clinical trials within the QA structure;
Performs gap analysis of quality and analyzes monthly trending reports of key quality indicators, as directed by the QA Manager, for assigned research teams to ensure continuous quality improvement;
Identifies gaps that may negatively impact clinical trial quality through ongoing review of QA Metrics;
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.
Addresses identified gaps through interventions with specific research team; and works with QA Program to implement system wide education and policy changes.
Assists with implementation and ongoing readiness for Accreditation of the Human Research Protection Program.
Provides support during external assessments, audits, and/or inspections;
Participates in HM Committees and/or other system initiatives related to clinical research.
Works with ORP and the QA Manager to develop, implements and maintain quality systems, and procedures that ensure compliance with FDA Good Clinical Practice (GCP), all applicable regulations, and HMRI standards.
Conducts or oversees the conduct of data driven quality improvement projects that affect individual as well as system processes.
This position description is not intended to be all inclusive, and the employee will also perform other reasonably related business duties as assigned by the immediate supervisor and other management as required. The Houston Methodist Hospital reserves the right to revise or change job duties and responsibilities as the need arises.
Bachelor’s degree required. Degree in life sciences or related field preferred
Minimum of 3 years related Clinical Trial Coordinator or equivalent experience commensurate with assigned area required. Quality Assurance experience within clinical research or health care arenas, desirable.
CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED
Optional Certificates: Quality Assurance, Six Sigma or similar certification
Certification for Clinical Trial Coordinator or Clinical Trial Associate.
SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
Excellent working knowledge of FDA regulations and GCP guideline.
Excellent written and oral communication skills.
Excellent working knowledge of the drug/device development process and clinical trial operations.
Ability to develop regulatory compliance 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.
Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies and treatments. The research institute was created 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, the research institute houses over 1,500 staff and trainees, 277 principal investigators and has more than 840 ongoing clinical trials.