Careers

Clinical Trials Quality Assurance Analyst

Full time, exempt

The Clinical Trials Quality Assurance Analyst is responsible for oversight of quality and regulatory compliance for clinical trials activities. QA staff work to identify and reduce regulatory and compliance risk by continuously monitoring and evaluating policies and practices to ensure compliance is built into the operational programs. The Clinical Trials Quality Assurance Analyst is responsible for ensuring clinical processes are conducted in accordance with guidelines and regulations. Develops, performs, and manages all clinical related quality assurance activities and communicates with leadership to take necessary actions to mitigate identified risks.

Supervisory Responsibilities

None

Duties and Responsibilities

• Manage relationships with existing and potential partners in a timely, professional manner.
• Engage with R&D Project Teams to develop and execute project plans; deliver on project milestones.
• Effectively summarize key information such as program goals, risks/opportunities, and progress/ timeline updates for periodic presentation to management.
• Compile succinct reports for select meetings, methodically track action items, and stay abreast of R&D collaboration tasks and activities.
• Regularly interact with multiple functional areas.

Ensure clinical trials activities are conducted in compliance with regulations

• Ensures that all processes contributing to the performance of a clinical trial are conducted in compliance with regulations and internal quality management system policies and procedures.

Coordinates implementation and maintenance of quality and compliance practices for the clinical program.

• Execute  strategic direction and prioritization on quality and compliance initiatives. Ensures the quality and compliance strategic planning activities are aligned with facility vision, mission, and objectives.
• Advises clinical staff in the review and interpretation of regulatory requirements impacting them and advises on necessary compliance actions.
• Participates in the development and review of protocols, processes, and product specifications to ensure compliance with regulatory and quality requirements.
• Perform routine evaluation of CRO performance and management.
• Educates leadership and operational personnel to ensure the regulatory requirements are understood at the level necessary to execute defined functions, including risks of non-compliance.
• Participates in the preparation of regulatory filings (IND, TMF, NDA’s, annual updates).
• Participates in establishing  strategic direction and prioritization on quality initiatives.
• Perform audits and develop monitoring methods to  to ensure Quality Management System (QMS) are appropriately implemented.
• Authors/approves and revises policies and procedures to define and support processes ensuring adherence to quality system requirements.
• Evaluates quality risks and makes recommendations to leadership.  Ensures quality concerns are prioritized and resources for support are identified.
• Establishes systems to collate and review quality metrics and ensures information is reviewed by executive leadership/management.
• Participates in annual planning for quality initiatives.
• Provides support as needed for on-site assessments.
• Reviews corrective action plans for deficiencies cited in assessments; ensures responses adequately address citations and requirements; reviews and endorses responses. Ensures that actions are taken and gaps are closed.
• Performs audits and gap analyses against regulatory and internal requirements. Effectively documents and communicates non-compliance issues and observations.
• Prepares assessment reports that are concise, and customer focused.
• Assists in the collection, analysis, and interpretation of monitoring data for regulatory issues (using statistical tools and graphs). Determines if, or recommends when, process improvements are needed.

Leads process improvement activities for the clinical program.

• Identifies potential improvements and leads process improvement teams as needed.
• Facilitates the documentation, design, and implementation of new and changed processes.
• Assists with the application of quality management tools for measuring improvements.
• Continually expands knowledge of quality management and regulatory principles.
• Serves as a resource and mentor in quality principles and regulatory requirements.

Demonstrates effective leadership skills.

• Promotes adaptation and flexibility in a rapidly changing environment. Acts as a change leader through team building and influence. Willingness to make difficult or unpopular decisions when warranted.
• Collaborates with colleagues to identify efficient solutions which meet the needs of a variety of stakeholders.
• Effectively evaluates risk, including issues which may involve ambiguity and have significant impact on business and/or personnel decisions. Utilizes good analytical skills, intuition, and other expert resources as appropriate to develop response/plans.
• Recognizes the need for self-development and growth needs to improve personal and professional skills.
• Additional activities as required.

Education and Experience Requirements

• A Bachelor’s degree in a science related field is required and a minimum of 5 years’ experience in a quality assurance and/or regulatory affairs role in an FDA regulated with clinical trials operation and management.

Required Experience and/or Qualifications

• Knowledge and experience working in industries regulated by FDA Good Clinical Practices, Good Manufacturing Practices, and ICH requirements is required. Additional experience with other requirements (Good Laboratory Practices, ISO, etc.) is highly desirable.
• Exceptional human relations and communication (written, verbal, and listening) skills are required. Should be very detail-oriented and have the ability to work independently and productively with minimal direction, and routinely exercise initiative and sound judgment.
• Strong analytic skills coupled with critical thinking skills are essential in this role. Must have demonstrated capacity to comprehend complex protocols, programs, and situations. The ability to exercise good judgment while under pressure and tight deadlines, and strong coping skills are required. Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.