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Clinical Quality Assurance Specialist

4 months ago

Burlington, United States Fractyl Health, Inc Full time

**Reports to**:Sr. Manager of Regulatory Affairs**:
**Position Summary**:
As our Clinical Quality Assurance Specialist, you will be a champion for Good Clinical Practices (GCP) compliance across our medical device development programs. You will ensure adherence to ICH requirements, manage clinical vendor selection and oversight, oversee clinical Standard Operating Procedures (SOPs), and lead Trial Master File (TMF) assessments. Additionally, you will play a key role in preparing for Bioresearch Monitoring (BiMO) audits and maintaining robust data management processes.

**Primary Responsibilities**:

- Ensure compliance with GCP principles and ICH guidelines throughout the clinical development lifecycle for medical devices.
- Develop, implement, and manage a comprehensive GCP training program for internal and external stakeholders.
- Lead the selection and qualification of clinical trial vendors (CROs, sites, etc.).
- Develop, review, and maintain clinical SOPs to ensure alignment with GCP and regulatory requirements.
- Conduct on-site audits for clinical study vendors and participating sites.
- Conduct regular TMF assessments to ensure completeness, accuracy, and traceability of clinical trial documentation.
- Develop and implement a quality management system for BiMO audit readiness, including risk assessments, mock audits, and gap analysis.
- Analyze audit findings, identify root causes of non-conformances, and develop corrective and preventive actions (CAPAs) for GCP deviations.
- Stay up-to-date on evolving GCP regulations and industry best practices.
- Timely documentation of activities and maintaining all required applicable training.

**Education** or Certification** Requirements**:

- Bachelor's degree in a science field (e.g., biology, engineering) and/or graduate degree in a related field.
- Certified Clinical Research Professional (CCRP) or equivalent certification is required.
- Certified auditor or equivalent experience in vendor assessments is a strong plus

**Professional Work** Experience**:

- Bachelor's and a minimum of 5 years of experience in clinical quality assurance or a related field, with a strong focus on GCP compliance.
- OR Master's and a minimum of 3 years of experience in clinical quality assurance or a related field, with a strong focus on GCP compliance.

**Qualifications and Skills**:

- In-depth knowledge of regulatory requirements and standards for medical device clinical trials (e.g., FDA regulations, GCP principles, ICH guidelines).
- Experience with clinical trial vendor management and oversight.
- Proven ability to develop, implement, and manage clinical SOPs.
- Expertise in TMF management and regulatory requirements.
- Proven experience with BiMO audits and regulatory inspections.
- Strong understanding of data management best practices for clinical trials.
- Excellent analytical, problem-solving, and critical thinking skills.
- Outstanding communication, interpersonal, and organizational skills.
- Excellent computer skills and the ability to work with enterprise platforms, EDC, PLM, CRM, etc.

**Other Essentials and Key Success Factors**:

- Successful track record of working in high-growth and dynamic organizations.
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit.
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well.
- Evidence of "hands-on" experience and expertise.
- Proven and successful track record as a team-player and collaborator in small working environments.
- Highly organized and detail oriented with a passion to deliver quality results.
- Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation.
- Highest levels of professionalism, confidence, personal values and ethical standards.

**Travel**:

- This position requires 10% - 25% travel.

***The **description** and requirements outlined** above are **general**; **additional** **requirements** may apply.