Program Development Specialist III (Regulatory Coordinator)

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.

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 https:// 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

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.

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: https:// uhr.rutgers.edu/non- discrimination-statement

Supplemental Questions

Required fields are indicated with an asterisk ().

Do you have a 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).

(Open Ended Question)

Do you have experience with IRB submissions and clinical research?

(Open Ended Question)

Can you lift up to 25 lbs?

(Open Ended Question)

Applicant Documents

Required Documents

Resume/CV

Optional Documents

Cover Letter/Letter of Application

Certifications/Licenses