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Quality Assurance Specialist

System One
New Haven, CT
  • Expired: August 14, 2021. Applications are no longer accepted.

Title: Quality Assurance Specialist

Location: New Haven, CT

Duration: Direct Hire (relocation candidates are welcome)

Schedule: M-F 37.5 hours, occasional weekend and evening hours

Target Start Date: ASAP

Responsibilities:

+ Works directly and in collaboration with leadership, Departmental leaders, investigators, research staff, HRPP and the IRB to facilitate the review the activities associated with human subject research in terms of safety, compliance, and integrity of clinical trials conducted and at collaborating institutions.

+ Evaluates clinical trial conduct to ensure research integrity and compliance with institutional policies, state and federal regulations, and Guidelines to Good Clinical Practice.

+ Identifies research non-compliance and reports to appropriate leadership

+ Provides educational and corrective action advice to faculty in preparation for FDA audits.

+ Serves as liaison between the investigator, the research team and the FDA during an actual inspection.

+ Records proceedings and summarizes inspection activity in real time.

+ Consults to investigators needing data safety monitoring plan details/information for their grant application.

+ Develops Data and Safety Monitoring Plans based on the risk assignment categories.

+ Provides direction to investigators to strengthen their research and ensure regulatory and protocol compliance.

+ Analyzes protocol to customize audit plans for protocol specific benchmarks in addition to standard audit reviews.

+ Assesses audit findings in the context of the larger program to identify trends or program wide areas of in need of improvement or education.

Requirements:

+ Experience in clinical research and also FDA regulations***

+ Master's Degree in a related field preferred or Bachelor Degree in related field and five years of related experience or an equivalent combination of education and experience.

+ GCP training required within 3 months of hire

+ Experience in auditing or monitoring of clinical trials.

+ SOCRA/ACRP (or equivalent) certification preferred

+ Demonstrable understanding of clinical research processes and procedures from study start-up to study close-out.

Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

System One

Address

New Haven, CT
06532 USA

Industry

Technology

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