Clinical Quality Specialist
1 Infinite Loop, SCV Cupertino, CA 95014 US
Target Pay Rate: 40-56.66/hr **salary will be commensurate with experience
ROLE AND RESPONSIBILITIES:
The Clinical Quality Specialist will work proactively and collaboratively with our clinical research teams, Quality Assurance, and other collaborating teams to ensure the successful delivery of high-quality clinical studies aligned with Good Clinical Practices (GCP) and applicable regulations. The Clinical Quality Specialist will also be responsible for supporting activities to improve quality and overall performance in Clinical Operations and other research teams. Further, this individual will ensure organizational alignment with the clinical Quality Management System (cQMS) and sharing of better practices in support of the cQMS. By fulfilling these responsibilities, the individual will aid in ensuring the high-quality execution of clinical studies in adherence to business plans.
Clinical Quality Assurance:
- Determine, negotiate, and agree on in-house quality procedures, standards and supporting documentation including interpretation and implementation of quality assurance standards.
- Work with staff to establish adequate procedures, standards, and systems. Draft quality assurance procedures and ensure review and approval in conjunction with other groups that impact the work conducted by the clinical research staff. Driving the timely completion of SOP updates.
- Develop and monitor corrective and preventive actions to ensure that quality issues are resolved and prevented in the future through proactive and coordinated training and process innovation.
- Plan and conduct audits related to clinical studies including, but not limited to, clinical vendor audits, study site audits, Trial Master File (TMF) audits, and sponsor pre-inspection preparation. Document internal audits and other quality assurance activities. Prepare reports to communicate outcomes of quality activities.
- Act as a catalyst for change and improvement in performance and quality across the group. Identify trends that could improve the quality of clinical studies and data collection processes.
- Manage and identify training gaps within the clinical research functions.
- Manage and participate in quality and continuous improvement efforts to increase overall effectiveness of the clinical research teams.
- 2-3 years of experience working in experience in an FDA regulated environment: pharmaceutical, medical device or equivalent industries. Experience in digital health tech preferred.
- Excellent attention to detail, sound judgment, and ability to work independently.
- Strong communication skills and ability to create a clear sense of direction is necessary.
- Ability to prioritize tasks and deliver assignments with high quality in a timely manner.
- Strong interpersonal skills; Ability to build strong relationships and positively motivate others.
- Ability to understand clinical quality assurance processes including, but not limited to, planning and conduct of site and vendor audits, Good Clinical Practices (GCP), Good Documentation Practices (GDP), and Quality Management Systems (QMS) is required.
- Detail oriented, excellent organizational and management skills.
- Ability to travel domestically up to 10% for clinical audits.
EDUCATION: Bachelor’s Degree or equivalent combination of education/experience in math,
science, Life Sciences, Pharmaceutical, or health related field required.
Remote/Flexible hours: open to remote, hybrid
Extension/Conversion: possibility to extend = yes
Hard skills: Medical Device Experience, FDA, Digital Health Tech
- Auditing Experience
- Clinical Research Experience
- Trimester File Experience
- Monitoring Experience – Clinical Study Quality Study
- QMS Experience (no equal to is acceptable)
- Great written and verbal communicaton
- Attention to Detail
- Organization Experience
Education/Certifications: Bachelors Degree – Life Science, Regulation Experience // Auditing Certification preferred
Disqualifiers: jumpy resume, less than 6 months
Performance indictors: meeting deliverables on audits, implementing feedback on team structures
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.