Senior/Clinical Research QA Specialist - Pulmonary Medicine
About The Position
The Senior/Clinical Research QA Specialist - Pulmonary Medicine will be responsible for reviewing and analyzing clinical trial data and documentation, providing guidance to clinical faculty and staff, developing monitoring plans, and ensuring compliance with protocols, SOPs, ICH GCP, and regulatory requirements. This role involves coordinating the development of regulatory sections for investigator-led protocols, maintaining SOPs, and serving as a primary resource for clinical trials staff. The specialist will also oversee the documentation of monitoring visits, prepare and execute monitoring plans, assist with audits and inspections, and develop improvement plans using quality improvement methods. Additionally, the role includes planning and executing quality assurance activities, consulting with stakeholders, managing projects, providing direction to team members, and developing and delivering quality assurance and regulatory training.
Requirements
- Bachelor's degree in a related field
- 5+ years of work experience in a related job discipline.
- SoCRA, ACRP, RAC or related certification within 18 months of external hire
Responsibilities
- Review and analyze clinical trial data and related documentation (internal and external).
- Provide guidance to clinical faculty and staff in clinical research documentation.
- Develop monitoring plans with indicators of quality, reliability, and adherence to SOPs.
- Develop and communicate outcome measures.
- Provide input into the development of new protocols and plans for implementing new trials as requested by Principal Investigators/Managers.
- Coordinate the development of regulatory sections of investigator-led protocols, e.g., data safety monitoring plans.
- Develop and maintain SOPs for clinical trials.
- Act as a primary resource on an ongoing basis for clinical trials staff, responding to questions and issues pertaining to study documentation, GCP, or other issues as requested.
- Oversee documentation of monitoring visits and report status for leadership and investigators.
- Develop comprehensive data safety monitoring plans for all clinical trial activities within the assigned department to ensure that trials are conducted in compliance with the protocol, SOPs, ICH GCP, federal, state, and local regulatory requirements.
- Prepare and execute monitoring plans both internally and at affiliate sites, including site visits to ensure protocol and regulatory compliance; data management tasks to ensure study data integrity; verify essential documents are accurate, complete, and maintained; and coordination of applicable follow-up activities.
- Assist in the development and implementation of action plans for external monitoring/audit follow-up.
- Assist in preparation and conduct of audits/surveys/inspections by FDA, DHHS, institutional, and accreditation agencies.
- Develop improvement plans using quality improvement methods (process improvement, continuous improvement, total quality management, etc.).
- Work with manager to plan and execute quality assurance activities and projects.
- Consult with stakeholders.
- Identify and use appropriate project management tools and concepts (scope management, planning, budget management, risk/issue management, communications management).
- Provide direction and guidance to team members on execution of deliverables.
- Develop and execute work plan, and provide support and oversight to team members regarding work plans.
- Set priorities for tasks based on importance and urgency.
- Delegate tasks effectively.
- Develop and provide quality assurance training and consultation for faculty, staff, and affiliate sites.
- Provide regulatory training (ICH GCP, FDA, DHHS, state, local, and institutional) and/or other training initiatives to faculty and staff, as assigned.
- Create work products and project deliverables, both independently and under direction of more senior-level team members.
- Understand and meet expectations for deliverable quality and timeliness.
- Oversee the creation of work products by others to ensure quality.
Benefits
- Comprehensive job description provided upon request.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
