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Program Development Analyst

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Position Details

Position Information

Recruitment/Posting Title Program Development Analyst
Job Category Staff & Executive - Healthcare - Administrative Services
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, transdisciplinary 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 Program Development Analyst for the Office of Human Research Services (OHRS), at the Rutgers Cancer Institute of New Jersey. The Program Development Analyst, under the direct supervision of the Program Director, will manage the regulatory activities of the Office of Human Research Services (OHRS). Among the key duties of this position are the following:

• Prepares documents for submission to the Network Institutional Review Board (IRB) offices, and follows up with correspondence to the IRB with the goal to obtain IRB approval, and manages and maintains regulatory documents for trials conducted in CINJ Oncology Group. (CINJOG)
• Manages receipt of patient registration in ONCORE, maintains and coordinates the monthly reporting of CINJOG clinical trial availability and accrual, and submit for compensation to sites for accrual.
• Communicates effectively with CINJOG Investigators, Network staff, Cancer Institute of New Jersey staff, industry sponsors, monitoring personnel from the national oncology cooperative groups, Cancer Trials Support Unit (CTSU) of the NCI, Food and Drug Administration (FDA), and others.
• Educates CINJOG and Statewide Network staff at participating institution on the electronic systems to obtain IRB approval.
• Coordinates the registration process for all electronic IRB systems (Rutgers, NCI, etc.), and the process by which CINJOG protocols are approved.
• Manages the CINJOG protocol amendment approval process, CINJOG process regarding annual review and updates, and the study closure process of CINJOG protocols.
• Collects and tracks all regulatory documentation (site IRB approvals, informed consent forms, CITI certificates, Rutgers Investigator Financial & Other Personal Interests Disclosure Form, Form FDA 1572s, Curriculum Vitae, medical licenses, lab norms, etc. from all participating investigators and from our partner and affiliate sites for all national cooperative oncology groups for which Cancer Institute of New Jersey is lead institution; and through Cancer Institute of New Jersey Oncology Group network sites that participate in CINJOG assigned studies where Cancer Institute of New Jersey is the coordinating center.

Position Status Full Time
Hours Per Week
Daily Work Shift
FLSA Exempt
Grade 24S
Position Salary
Annual Minimum Salary 57589.000
Annual Mid Range Salary 69775.500
Annual Maximum Salary 81962.000
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 plus (3) years experience in clinical research regulatory affairs.

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 PowerPoint and Oncore.
• The ideal candidate will have a clear understanding of Food & Drug Administration (FDA), Office of Human Research Protections (OHRP), National Institutes of Health (NIH) and Health Insurance Portability & Accountability Act (HIPPA) regulations, possess a considerable understanding of Good Clinical Practice (GCP) guidelines, institutional guidelines and SOP’s set forth by CINJ and Rutgers.
• Must be capable of independent decision-making, and multitasking.
• Must have excellent organization, communication and interpersonal skills, hold him/herself accountable to high standards of professional excellence, be able to maximize resources, and seek and accept personal and professional responsibility.
• Equivalent experience, education and/or training may be substituted for the education requirements.

Preferred Qualifications

• Association of Clinical Research Professional (ACRP) certification or Society of Clinical Research Associates (CCRP), certification.
• Clinical research project administration experience in the pharmaceutical industry.

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 17ST3748
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 a Bachelor's Degree?
    • Yes
    • No
  2. * Do you have minimum of three (3) years of experience in clinical research regulatory affairs?
    • Yes
    • No

Applicant Documents

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