Program Assistant (Regulatory Affairs)

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Position Details
Position Information
Recruitment/Posting Title Program Assistant (Regulatory Affairs)
Job Category Staff & Executive - Research Support (Laboratory/Non-Laboratory)
Department Cancer Institute of New Jersey
Overview
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.
Curiosity and Discovery, Integrity, Collaboration, Respect and Caring, Perseverance.
Posting Summary
Rutgers, The State University of New Jersey is seeking a Program Assistant (Regulatory Affairs) in the Office of Human Research Services at Rutgers Cancer Institute of New Jersey.
The primary purpose of the Program Assistant position is to support Statewide regulatory activities for theOffice of Human Research Services ( OHRS ) at the Rutgers Cancer Institute of New Jersey. Assists with the implementation and start-up activities of assigned clinical trials and provides program support to the Regulatory Affairs team.
Among the key duties of this position are the following:

• Coordinates all aspects of Statewide protocol submission for assigned clinical trials. Communicates with the appropriate investigator, research staff and leadership regarding protocol submissions and approval status.
• Maintains and disseminates accurate list of pending trials to participating sites and OHRS leadership. Serves as the resource for current regulatory information/statuses for assigned protocols.
• Assists regulatory team with creating and maintaining regulatory file for each study within OnCore® and eREG®.
• Collects and tracks all regulatory documentation (site IRB approvals, informed consent forms, Form FDA 1572s, Curriculum Vitae, Medical License, lab norms) from health system sites for all trials. Ensures regulatory documentation is forwarded to the appropriate regulatory coordinator in a timely fashion.
• Assists investigators and research staff with obtaining and maintaining CTEP IDs. Maintains expiration dates in OnCore®.
• Prepares and submits all necessary documents to the Institutional Review Board. Ensures regulatory approvals are obtained.
• Verifies work order completion between Rutgers and RWJ Barnabas Health before opening trial to accrual in OnCore®.
• Communicates effectively with Cancer Center/Statewide investigators and site research staff. Responds to routine questions related to regulatory matters and refers more complex questions to others as appropriate.
• Serves as the primary contact for the Shared Investigator Program ( SIP ). Assists investigators and staff with obtaining profiles. Maintains site profiles for CINJ and all health system sites.

Position Status Full Time
Hours Per Week
Daily Work Shift
Work Arrangement
FLSA Exempt
Grade 19S
Position Salary
Annual Minimum Salary 49566.000
Annual Mid Range Salary 59113.000
Annual Maximum Salary 69919.000
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.
Seniority Unit
Terms of Appointment Staff - 12 month
Position Pension Eligibility ABP
Qualifications
Minimum Education and Experience

• Equivalent education, experience, and/or training may be substituted for the degree.
• Bachelor’s Degree plus one (1) year related experience.

Certifications/Licenses
Required Knowledge, Skills, and Abilities

• Demonstrated excellent organizational 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.
• Demonstrated effective oral and communication skills.
• Must be computer literate with proficiency and working knowledge of database and reporting tools such as Microsoft Word, Excel,Access, and PowerPoint.

Preferred Qualifications

• Bachelor’s Degree plus one (1) year related experience in a clinical research regulatory capacity.

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 23ST0997
Posting Open Date
Special Instructions to Applicants
Regional Campus Rutgers Biomedical and Health Sciences (RBHS)
Home Location Campus Downtown New Brunswick
City New Brunswick
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 (https://policies.rutgers.edu/60-1-35-currentpdf) , 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 (https://policies.rutgers.edu/sites/default/files/100-3-1-current.pdf) , 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: http://uhr.rutgers.edu/non-discrimination-statement
Supplemental Questions