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Quality Specialist (Phase I)

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Position Details

Position Information

Recruitment/Posting Title Quality Specialist (Phase I)
Job Category Staff & Executive - Research Support (Laboratory/Non-Laboratory)
Department CINJ-OHRS
Overview

Rutgers Cancer Institute of New Jersey Vision, Mission, and Core Values:

Our vision is to be a statewide, national and world leader of scientific discovery, trans disciplinary engagement, translation, patient care and education that improves outcomes for cancer patients and populations.

We will accomplish this by conducting innovative basic, clinical and population research and cutting-edge patient-centered care that expands our understanding of the etiology and biology of cancer; facilitates the rapid translation of laboratory-based discoveries into human studies; develops new approaches and interventions for cancer prevention that decrease cancer incidence and mortality; and develops new and better therapies to decrease suffering and mortality from cancer.

Core Values:

Curiosity and Discovery, Integrity, Collaboration, Respect and Caring, Perseverance.

Posting Summary

Rutgers, The State University of New Jersey, is seeking a Quality Specialist for the Operations department for Rutgers Cancer Institute of New Jersey. The primary purpose of the Quality Specialist position is to conduct quality assurance audits of all phase I research protocols and research operations to ensure compliance with FDA, GCP, ICH guidelines and Rutgers Cancer Institute of New Jersey standard operating procedures (SOPS) and guidelines.

Among the key duties of this position are the following:

• Assists the Manager, Quality Assurance and Data Monitoring, in the organization and development of a quality assurance infrastructure to include assisting in the implementation of research specific quality assurance activities in collaboration with other staff and leadership of the Office of Human Research Services as necessary.
• Reviews and analyzes documents, monitors research and administrative activities, and provides education to Investigators and research staff.
• Assists 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.
• Facilitates initial and ongoing research educational seminars, workshops, etc. for Cancer Institute of New Jersey research personnel, Investigators, faculty, staff and students.
• 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.
• Supports the implementation of priorities within appropriate time lines for the conduct of quality assurance audits that meetthe standards and requirements described in the Rutgers Cancer Institute of New Jersey Data and Safety Monitoring Plans(s).

Position Status Full Time
Hours Per Week
Daily Work Shift
FLSA Exempt
Grade 26S
Position Salary
Annual Minimum Salary 62816.000
Annual Mid Range Salary 76248.500
Annual Maximum Salary 89681.000
Standard Hours 37.50
Union Description HPAE, Local 5094
Payroll Designation PeopleSoft
Benefits

Information about the benefits provided to Rutgers employees can be found at: http://uhr.rutgers.edu/benefits/benefits-overview

Seniority Unit
Terms of Appointment Staff - 12 month
Position Pension Eligibility ABP

Qualifications

Minimum Education and Experience

• Bachelor’s Degree in related field.
• 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.
• Equivalent education, experience and/or training may be substituted for the degree requirement.

Required Knowledge, Skills, and Abilities

• Experience 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.
• 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.

Preferred Qualifications

• Master’s Degree
• Oncology experience

Equipment Utilized
Physical Demands and Work Environment

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

WORK ENVIRONMENT: Office environment. Moderate noise.

Special Conditions

Posting Details

Posting Number 17ST3376
Posting Open Date
Special Instructions to Applicants
Regional Campus Rutgers Biomedical and Health Sciences (RBHS)
Home Location Campus Downtown New Brunswick
Location Details

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

Supplemental Questions

Required fields are indicated with an asterisk (*).

  1. * Do you have at least 3 years' experience in oncology clinical trials research in an academic, pharmaceutical or governmental setting?
    • Yes
    • No

Applicant Documents

Required Documents
  1. Resume
Optional Documents
  1. Cover Letter/Letter of Application