Quality Data Analyst

Position Details

Position Information

Recruitment/Posting Title	Quality Data Analyst
Job Category	Staff & Executive
Department	CINJ-OHRS Quality Assurance
Overview	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.   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.   Curiosity and Discovery, Integrity, Collaboration, Cultivating Diversity, Respect and Caring, Perseverance.
Posting Summary	Rutgers, The State University of New Jersey is seeking a Quality Data Analyst within the Rutgers Cancer Institute of New Jersey. The primary purpose of the Quality Assurance Specialist position is to conduct quality assurance audits of research protocols and research operations to ensure compliance with FDA (SOPS) and guidelines. The specialist will review and analyze documents, monitor research and administrative activities, and provide education to Investigators and research staff. The specialist will 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. The specialist will also facilitate initial and ongoing research educational seminars, workshops, etc. for Cancer Institute of New Jersey research personnel, Investigators, faculty, staff and students.   Among the key duties for this position are 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 RCINJ’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 of New Jersey Data and Safety Monitoring Plans(s). Assists with implementing the quality assurance and data monitoring activities for clinical research conducted by RCINJ 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.
Position Status	Full Time
Hours Per Week
Daily Work Shift
Work Arrangement
FLSA	Exempt
Grade	30S
Position Salary
Annual Minimum Salary	85909.000
Annual Mid Range Salary	103537.000
Annual Maximum Salary	123261.000
Standard Hours	37.50
Union Description	HPAE, Local 5094
Payroll Designation	PeopleSoft
Benefits	Rutgers offers a comprehensive benefit program to eligible employees. For details, please go to http://uhr.rutgers.edu/benefits/benefits-overview . Rutgers also offers a benefit program to eligible full-time postdoctoral fellow students. For details, please go to https://finance.rutgers.edu/healthcare-risk/insurance/postdoctoral-health-insurance.
Seniority Unit
Terms of Appointment	Staff - 12 month
Position Pension Eligibility	ABP

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.
Certifications/Licenses
Required Knowledge, Skills, and Abilities	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.  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. Equivalent education, experience and/or training may be substituted for the degree requirement.
Preferred Qualifications	Oncology experience is preferred.
Equipment Utilized
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.
Special Conditions

Posting Details

Posting Number	24ST0002
Posting Open Date	12/31/2023
Special Instructions to Applicants
Regional Campus	Rutgers Biomedical and Health Sciences (RBHS)
Home Location Campus	Rutgers University - New Brunswick
City	New Brunswick
State	NJ
Location Details

Pre-employment Screenings

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

Immunization Requirements

Under Policy 60.1.35 Immunization Policy for Rutgers Employees and Prospective Employees , Rutgers University requires all prospective employees to provide proof that they are vaccinated against COVID-19 prior to commencement of employment, unless the University has granted the individual a medical or religious exemption. Rutgers University may require certain prospective employees to receive an updated (bivalent) vaccine dose. 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.

Affirmative Action/Equal Employment Opportunity Statement

It is university policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, affectional or sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As an institution, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. For additional information please see the Non-Discrimination Statement at the following web address: http://uhr.rutgers.edu/non-discrimination-statement