Quality Data Analyst

Rutgers, The State University of New Jersey is seeking a Quality Data Analyst within the Office of Human Research Services at the Rutgers Cancer Institute.

The primary purpose of the Quality Data Analyst position is to conduct quality assurance audits of research protocols and research operations to ensure compliance with FDA, GCP, ICH guidelines and Rutgers Cancer Institute standard operating procedures (SOPS) and guidelines. The Quality Data Analyst will review and analyze documents, monitor research and administrative activities, and provide education to investigators and research staff.

The Quality Data Analyst will also assist in the preparation of reports on audit findings and make recommendations for corrective actions to ensure resolution of and deviations from SOPs, protocols, and GCP and ICH guidelines. Additionally, the Quality Data Analyst will facilitate initial and ongoing research educational seminars, workshops, etc. for Rutgers Cancer Institute research personnel, Investigators, faculty, staff and students.

Essential Duties and Responsibilities include the following:

• Provides support for the development of center initiatives in quality assurance and data monitoring to foster current and future clinical research services that facilitate the mission and contribute to achieving the RCI's overall quality research objectives.
• Assists with coordination of all activities of the Quality Assurance and Data Monitoring Division of the Office of Human Research Services.
• Supports the implementation of priorities within appropriate time lines for the conduct of quality assurance audits that meet the standards and requirements described in the Rutgers Cancer Institute Data and Safety Monitoring Plans(s).
• Assists with implementing the quality assurance and data monitoring activities for clinical research conducted by RCI to meet defined objectives.
• Assists the Manager, Quality Assurance and Data Monitoring, with implementing a system for the Quality Assurance and Data Monitoring Division to provide continuous administrative support to the Human Research Oversight Committee (HROC). This includes gathering data for the Chair of HROC, development/dissemination of meeting minutes, creation/distribution of HROC action memos, generating FDA IND annual reports as applicable and quarterly summary reporting to the External Data Safety Monitoring Committee.

Minimum Education and Experience:

• Bachelor's Degree in related field (Master's Degree preferred), plus a minimum of three (3) years experience in oncology clinical trials research in an academic, pharmaceutical or governmental setting required, of which a minimum of one (1) year should have been in quality assurance and data monitoring.
• Experience should include: conducting audits at clinical trial sites, relevant education and qualification in Science, Medical or Pharmacology disciplines.
• Hands-on experience in auditing activities in a government and/or pharmaceutical industry setting.
• Working knowledge of United States Federal regulations and Medical Device regulations is required.
• Equivalent education, experience and/or training may be substituted for the degree requirement.

Physical Demands and Work Environment:

PHYSICAL DEMANDS:

• Standing, sitting, walking, talking and hearing.
• No special vision requirements.
• Lifting up to 25 lbs.

WORK ENVIRONMENT:

• Office environment. Moderate noise.