Quality Data Analyst

Overview

RUTGERS CANCER INSTITUTE VISION, MISSION, AND CORE VALUES:

VISION:

Through our science, our evidence-based actions, our openness, and our respect for those we serve, we will advance cancer-focused research worldwide and reduce the burden of cancer in our catchment area. By engaging with and empowering our exceptionally diverse populations, and addressing their questions and fears, we will engender hope for cancer patients and their families and play a critical role in strengthening the fabric of our communities by gaining and protecting their trust and providing access to the outstanding oncology care each person deserves.

MISSION:

Our mission is to accelerate scientific discovery focused on understanding cancer, innovating cancer treatment, and improving cancer prevention; to provide outstanding, novel, and compassionate patient care; to provide evidence-based and culturally informed education to physicians, nurses, researchers, staff, and the community; and to achieve cancer health equity in our state through outreach to and engagement of our extraordinarily diverse communities.

CORE VALUES:

• Curiosity and Discovery: encouraging an environment of continuous inquiry, creativity, and innovation to generate new knowledge
• Integrity: earning the trust of those we serve and each other through honesty, transparency, accountability, and continuous reflection
• Collaboration: approaching all opportunities with an understanding that together we are better and can achieve more; promoting and maintaining an environment of teamwork and shared knowledge
• Respect and Caring: consistently demonstrating caring, compassion, and respect through our words and actions
• Perseverance: maintaining an unwavering commitment to our mission; embracing change, overcoming obstacles, and creating and recreating the path to achieve our goals

Posting Summary

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

• 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.

Qualifications

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.

Required Knowledge, Skills, and Abilities

• Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel, Access and PowerPoint.
• Demonstrated ability to be focused on customer service and results, to be flexible, self-motivated and to set priorities.
• Outstanding human relations skills and the ability to function in a team environment are required.

Preferred Qualifications

• Oncology experience is preferred.
• Master's Degree preferred.

Benefits

Rutgers provides a comprehensive benefits package to eligible employees. The specific benefits vary based on the position and may include:

• Medical, prescription drug, and dental coverage
• Paid vacation, holidays, and various leave programs
• Competitive retirement benefits, including defined contribution plans and voluntary tax-deferred savings options
• Employee and dependent educational benefits (when applicable)
• Life insurance coverage
• Employee discount programs

Special Conditions

Pre-employment Screenings

All offers of employment are contingent upon successful completion of all pre-employment screenings.

Immunization Requirements

Under Policy 100.3.1 Immunization Policy for Covered Individuals, if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption. Additional infection control and safety policies may apply. Prospective employees should speak with their hiring manager to determine which policies apply to the role or position for which they are applying. Failure to provide proof of vaccination for any required vaccines or obtain a medical or religious exemption from the University will result in rescission of a candidate's offer of employment or disciplinary action up to and including termination.