Program Development Specialist III (Regulatory Coordinator)
Full Time
Newark, NJ 07102
Posted
Job 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.
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:
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.
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.
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
- 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
- Lifting up to 25 lbs.
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
Newark
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 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. Employees who are not eligible for a booster at the time of an offer of employment must provide proof they have received a booster upon eligibility and upload proof of same. 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.
gatheringourvoice.org is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, gatheringourvoice.org provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, gatheringourvoice.org is the ideal place to find your next job.