Program Development Specialist III (Regulatory Coordinator) job vacancy in Rutgers University (Newark, NJ 07102)

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Company name : Rutgers University
Location : Newark, NJ 07102
Position : Program Development Specialist III (Regulatory Coordinator)

Description :
Position Details

Position Information

Recruitment/Posting Title

Program Development Specialist III (Regulatory Coordinator)

Job Category

Staff & Executive – Medical (Clinical) – Infectious Diseases/Geographic Medicine

Department

NJMS-Medicine-Infectious Diseases

Overview

New Jersey’s academic health center, Rutgers Biomedical and Health Sciences (RBHS) takes an integrated approach to educating students, providing clinical care, and conducting research, all with the goal of improving human health. Aligned with Rutgers University–New Brunswick and collaborating university wide, RBHS includes eight schools, a behavioral health network, and five centers and institutes that focus on cancer treatment and research, neuroscience, advanced biotechnology and medicine, environmental and occupational health, and health care policy and aging research.

Our faculty are teachers, clinicians, and scientists with unparalleled experience who advance medical innovation and provide patient care informed by the latest research findings. We offer an outstanding education in medicine, dentistry, pharmacy, public health, nursing, biomedical research, and the full spectrum of allied health careers.

Our clinical and academic facilities are located throughout the state—at Rutgers University–New Brunswick ,including Piscataway; and at locations in Newark, Scotch Plains, Somerset, Stratford, and other locations. Clinical partners include Robert Wood Johnson University Hospital in New Brunswick, Newark’s University Hospital in Newark, and other affiliates.

Through this community of healers, scientists, and scholars, Rutgers is equipped as never before to transform lives.

Posting Summary

Rutgers The State University of New Jersey is seeking a Program Development Specialist III (Regulatory Coordinator) for the Department of Medicine at the New Jersey Medical School.

Under the direction of the Principal Investigators, Data and Operations Management Center (DOMC) Director, and other leadership, the Program Development Specialist (Regulatory Coordinator) is responsible for overseeing the regulatory program for the DOMC group.

Among the key duties of the position are the following:

Prepares regulatory reports, studies, and surveys from which a supervisor may develop policies and programs. Assists in the compilation of regulatory data for the preparation of proposals for funding.
Prepares responses to inquiries pertaining to regulatory policies or programs from within the Department, and from collaborating institutions and partners.
Performs basic regulatory program development. Maintains a database for tracking IRB submissions, modifications, continuing reviews, reportable events, MTA/DUA agreements, FWAs at Rutgers and collaborating sites.
Coordinates administrative activities of the regulatory program including, but not limited to, completing IRB submissions (new study applications, modifications, annual reviews, reportable events); developing consent forms and other documents necessary for IRB submissions (e.g. local context supplements, recruitment scripts, appendices); promptly responding to IRB and reviewer comments. Maintains protocol and ICF version control.
Assists in the computerization of research information related to regulatory matters. Organizes the development of protocol-specific regulatory binders.
Understands and adheres to RBHS’s compliance standards as they appear in RBHS Corporate Compliance Policy, Code of Conduct and Conflict of Interest Policy.
Keeps abreast of all federal, state and RBHS regulations, laws and policies as they presently exist and as they change or are modified.

Position Status

Full Time

Hours Per Week

Daily Work Shift

Work Arrangement

FLSA

Exempt

Grade

18S

Position Salary

Annual Minimum Salary

47546.000

Annual Mid Range Salary

56638.000

Annual Maximum Salary

66750.000

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.

COVID-19 Immunization Requirement

Under Policy 60.1.35, Rutgers University requires all prospective employees to provide proof that they are fully vaccinated and have received a booster (where eligible) against COVID-19 prior to commencement of employment, unless the University has granted the individual a medical or religious exemption. Prospective employees who are not eligible for a booster at the time of an offer of employment must provide proof they have received a booster within two weeks (14 calendar days) of eligibility. Based on current guidance, individuals are considered fully vaccinated against COVID-19 two weeks after receiving the final dose of any COVID-19 vaccine authorized or approved for use in the United States by the United States Food and Drug Administration (FDA) and recommended by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC). Eligibility for a booster against COVID-19 varies and is explained on the University’s web site located at https://coronavirus.rutgers.edu/covid-19-vaccine. Failure to provide proof of primary vaccination and booster will result in rescission of a prospective employee’s offer of employment and/or disciplinary action up to and including termination.

Seniority Unit

Terms of Appointment

Staff – 12 month

Position Pension Eligibility

ABP

Qualifications

Minimum Education and Experience

Master’s Degree in a relevant science plus one (1) year of related research experience, or a Bachelor’s Degree in a relevant science plus two (2) years of related research experience.
Equivalent experience, education, and/ or training may be substituted for the education requirements.

Certifications/Licenses

Required Knowledge, Skills, and Abilities

The ideal candidate will have experience with IRB submissions and clinical research.
The candidate will be highly organized and able to prioritize tasks in challenging situations while meeting strict deadlines.

Preferred Qualifications

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

22ST2025

Posting Open Date

Special Instructions to Applicants

Regional Campus

Rutgers Biomedical and Health Sciences (RBHS)

Home Location Campus

Newark (RBHS)

City

State

Location Details

Pre-employment Screenings

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

Infection Control and Safety

This position is subject to all Rutgers University policies, including TB surveillance and other infection control and safety policies. Please review the Tuberculosis Surveillance Policy for additional information.

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