Position Details

Position Information

Recruitment/Posting Title
Manager Regulatory Affairs

Job Category
Staff & Executive – Other

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.

Rutgers RBHS is an anchor institution that boasts locations in Newark, New Jersey, a city of promise.

Posting Summary
Rutgers, the State University of New Jersey is seeking a Manager Regulatory Affairs , fot the Department of Medicine within the New Jersey Medical School. Under direction, the Manager Regulatory Affairs serves as a member of a multidisciplinary research team, utilizing specialized knowledge, skills, and competencies in human subjects protection and regulatory compliance. The Manager Regulatory Affairs will oversee all regulatory activities within the group: completing and tracking IRB submissions, liaising with Rutgers Research Contract Services, providing study regulatory coordination with collaborating institutions, and performing other related activities.

Among the key duties of this position are the following:

  • Completes IRB submissions (new study applications, modifications, annual reviews, reportable events); develops consent forms and other documents necessary for IRB submissions (e.g. local context supplements, recruitment scripts, appendices); promptly responds to IRB and reviewer comments; troubleshoots issues with IRB.
  • Organizes the development of protocol-specific regulatory binders, communications with sponsor representatives and collaborator regulatory communications, protocol and ICF version control.
  • Develops and maintains a database for tracking IRB submissions, modifications, continuing reviews, reportable events, MTA/DUA agreements, FWAs at Rutgers and collaborating sites.
  • Assists PIs in developing clinical protocols from information provided in grant proposals.
  • Works with PIs to develop/update human subjects documents for grant submissions and NIH progress reports. Works with PIs to develop goals/accomplishments documents for NIH.

Position Status
Full Time

Hours Per Week

Daily Work Shift

FLSA
Exempt

Grade
27S

Position Salary

Annual Minimum Salary
79037.000

Annual Mid Range Salary
99983.000

Annual Maximum Salary
120927.000

Standard Hours
37.50

Union Description
Non-Union

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
Rutgers University requires all new 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 employee a medical or religious exemption. Employees who are not eligible for a booster at the time of an offer of employment provide proof they have received a booster upon eligibility and upload proof of same. Based on current guidance, individuals are considered fully vaccinated against COVID-19 two weeks after receiving the final dose of a vaccine approved or authorized for emergency use in the United States or a vaccine that has been listed for emergency use by the World Health Organization. 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 candidate’s offer of employment 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 related field plus three (3) years of research experience, two (2) of which shall have included university level regulatory affairs.

Certifications/Licenses

Required Knowledge, Skills, and Abilities
  • Strong regulatory research specific knowledge base (IRB, informed consent, human subjects protection).
  • Solid knowledge of computer software programs (Microsoft Office, databases, etc.).
  • Demonstrated ability to maximize resources on a continued basis.
  • Must be detail oriented.
  • Must have excellent organization, communication, and interpersonal skills. Must hold self-accountable to high standards of professional excellent.

Preferred Qualifications
  • Experience in a research university setting.

Equipment Utilized

Physical Demands and Work Environment
  • Must be able to lift or exert force up to ten (10) pounds.

Special Conditions
  • Must be able to travel to international sites.

Posting Details

Posting Number
22ST0317

Posting Open Date

Special Instructions to Applicants

Regional Campus
Rutgers Biomedical and Health Sciences (RBHS)

Home Location Campus
Newark (RBHS)

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.