Senior Quality Specialist (Clinical Trials)
Location
New Haven, CT | United States
Job description
Title: Senior Quality Specialist
Location: New Haven, CT
Schedule: M-F 37.5 hours, occasional weekend and evening hours
Type: Direct Hire
Our client is seeking an individual with strong background in quality and/or compliance for clinical trials. Some monitoring or experience running internal QA auditing type programs ideal.
Requirements:
- Bachelor’s Degree in degree in a health-related discipline, or other related field, and a minimum 5 years’ experience working in a clinical research environment, or an equivalent combination of education and related experience.
- Demonstrated mastery of human subjects research related standards and ability to interpret, analyze, apply, and communicate applicable ethical principles, laws, regulations, guidance, policies, academic & industry trends, and other standards. Demonstrable understanding of clinical research review, approval & monitoring processes from start-up to close-out.
- Strong computer skills required, including strong competency in Microsoft Office programs (Word, Excel, PowerPoint, etc.).
- Oncology clinical research experience strongly preferred.
- Preferred competency with Clinical Trials Management Systems (CTMS) and Electronic Medical Record (EMR) systems.
Preferred Licenses or Certifications:
SOCRA/ACRP (or equivalent) certification preferred
Responsibilities:
The Sr. Quality Specialist is responsible for assessing the quality of clinical trials conducted. This position participates in all aspects of clinical research integrity, compliance and privacy initiatives, including workforce orientation, incident response and documentation, clinical research monitoring and quality reviews, staff education on clinical research compliance topics, and providing support for policy and procedure development.
- Conducts risk based internal monitoring and quality control reviews of supported studies and research activities, with a focus on moderately to highly complex studies, and reviewing compliance with study protocols, Good Clinical Practices, and policies and procedures.
- Work with Director, Quality and Education to provide feedback, deficiencies and common trends identified in quality review to ensure timely and effective change control to improve overall quality.
- Leads the internal monitoring and quality control review effort by mentoring and the planning and conduct of monitoring and quality reviews.
- Develops corrective and preventive actions (CAPAs) in collaboration with Clinical Research Managers and leaders, when issues are detected in order to avoid further deviations or other compliance issues. Also responsible for quality follow-up on CAPAs that are implemented, in order to ensure adherence and effectiveness.
- Coordinates and manages the preparation of all external audits conducted by study sponsors.
- Collaborates and supports Quality Assurance & Monitoring team on regulatory authority (e.g.: FDA, EMA) inspection preparedness for CTO supported trials as needed.
- Partner with the Sr. Training Specialist to educate and provide guidance to staff members concerning internal processes and procedures which ensure that all aspects of clinical studies are conducted according to Good Clinical Practice Guidelines.
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