Rutgers University
Overview
Position Details
and related information have been consolidated from the posting. Rutgers Cancer Institute seeks a Research Scientist II in the Office of Human Research Services (OHRS) to support the conduct of clinical research and regulatory activities. Posting Summary:
Rutgers, The State University of New Jersey is seeking a Research Scientist II in the Office of Human Research Services (OHRS) Department at the Rutgers Cancer Institute. The Research Scientist II plays a critical role in facilitating the successful conduct of clinical research by providing comprehensive regulatory support to investigators. This position assists with the development and writing of clinical trial protocols, informed consent forms, and ensures accurate and timely management of all FDA submissions, including Investigational New Drug (IND) applications and other regulatory documents. It also oversees the registration and maintenance of clinical trial information on ClinicalTrials.gov. The ideal candidate has a strong understanding of FDA regulations, excellent writing and communication skills, and a meticulous approach to regulatory compliance. Vision, Mission, and Core Values VISION:
Through our science, our evidence-based actions, our openness, and our respect for those we serve, we will advance cancer-focused research worldwide and reduce the burden of cancer in our catchment area. By engaging with and empowering diverse populations, we will engender hope for cancer patients and their families and strengthen community trust and access to outstanding oncology care. MISSION:
Our mission is to accelerate scientific discovery focused on understanding cancer, innovating cancer treatment, and improving cancer prevention; to provide outstanding, novel, and compassionate patient care; to provide evidence-based and culturally informed education; and to achieve cancer health equity through outreach to diverse communities. CORE VALUES:
Curiosity and Discovery; Integrity; Collaboration; Respect and Caring; Perseverance. These values guide our work and interactions. Responsibilities
Serve as a primary resource for investigators on FDA regulations, ICH-GCP guidelines, and other regulatory requirements related to investigator-initiated clinical trials. Provide expert advice on regulatory strategy and compliance throughout the clinical trial lifecycle. Collaborate with principal investigators, study teams, and stakeholders to assist in writing and developing clear, scientifically sound clinical trial protocols, ensuring adherence to regulatory guidelines and internal policies. Guide investigators on protocol design elements to ensure acceptability to regulators and ethical considerations. Prepare and submit documentation to Institutional Review Boards (IRBs) for initial study approval, amendments, continuing reviews, and other required reports. Serve as the primary point of contact for IRB communications, addressing queries in a timely manner. Review trial summary reports and ensure quality of data abstractions by cross-checking data and verifying contracts from source documents for accuracy. Qualifications
Minimum Education and Experience: Master's Degree in Regulatory Affairs plus a minimum of three (3) years of experience in a clinical research, healthcare, or higher education environment, with focus on research, regulatory, clinical trials, and/or FDA submission experience. Experience in preparing and managing FDA submissions is required. Required Knowledge, Skills, and Abilities: Detail-oriented with excellent organizational, communication, and interpersonal skills; able to maintain high professional standards and responsibly manage resources. Proficient with Microsoft Word, Excel, Access, and PowerPoint; computer literate with experience using databases and reporting tools. Preferred Qualifications: Experience assisting with clinical trial protocol and informed consent form writing is preferred. Benefits
Rutgers offers a comprehensive benefits package to eligible employees, including: Medical, prescription drug, and dental coverage Paid vacation, holidays, and various leave programs Competitive retirement benefits and savings options Employee and dependent educational benefits Life insurance coverage Employee discount programs For detailed information on benefits and eligibility, please visit: http://uhr.rutgers.edu/benefits/benefits-overview. Position Details
Position Status:
Full Time Working Hours (per week):
37.50 Work Arrangement:
This position requires a fully on-site work arrangement. Union:
HPAE 5094 Seniority Unit:
– Terms of Appointment:
Staff - 12 month Position Pension Eligibility:
ABP Posting Details
Posting Number:
25ST1841 Posting Open Date:
08/26/2025 Regional Campus:
Rutgers Biomedical and Health Sciences (RBHS) Home Location Campus:
Rutgers University - New Brunswick City/State:
New Brunswick, NJ Pre-employment and Compliance
All offers of employment are contingent upon successful completion of pre-employment screenings. Immunization policies may apply for on-site roles; vaccinations or exemptions may be required and failure to comply may rescind an offer. Affirmative Action/Equal Employment Opportunity:
Rutgers is an equal opportunity employer. We value diversity and prohibit discrimination or harassment on the basis of protected status. For more information, see the Non-Discrimination Statement: http://uhr.rutgers.edu/non-discrimination-statement
#J-18808-Ljbffr
Position Details
and related information have been consolidated from the posting. Rutgers Cancer Institute seeks a Research Scientist II in the Office of Human Research Services (OHRS) to support the conduct of clinical research and regulatory activities. Posting Summary:
Rutgers, The State University of New Jersey is seeking a Research Scientist II in the Office of Human Research Services (OHRS) Department at the Rutgers Cancer Institute. The Research Scientist II plays a critical role in facilitating the successful conduct of clinical research by providing comprehensive regulatory support to investigators. This position assists with the development and writing of clinical trial protocols, informed consent forms, and ensures accurate and timely management of all FDA submissions, including Investigational New Drug (IND) applications and other regulatory documents. It also oversees the registration and maintenance of clinical trial information on ClinicalTrials.gov. The ideal candidate has a strong understanding of FDA regulations, excellent writing and communication skills, and a meticulous approach to regulatory compliance. Vision, Mission, and Core Values VISION:
Through our science, our evidence-based actions, our openness, and our respect for those we serve, we will advance cancer-focused research worldwide and reduce the burden of cancer in our catchment area. By engaging with and empowering diverse populations, we will engender hope for cancer patients and their families and strengthen community trust and access to outstanding oncology care. MISSION:
Our mission is to accelerate scientific discovery focused on understanding cancer, innovating cancer treatment, and improving cancer prevention; to provide outstanding, novel, and compassionate patient care; to provide evidence-based and culturally informed education; and to achieve cancer health equity through outreach to diverse communities. CORE VALUES:
Curiosity and Discovery; Integrity; Collaboration; Respect and Caring; Perseverance. These values guide our work and interactions. Responsibilities
Serve as a primary resource for investigators on FDA regulations, ICH-GCP guidelines, and other regulatory requirements related to investigator-initiated clinical trials. Provide expert advice on regulatory strategy and compliance throughout the clinical trial lifecycle. Collaborate with principal investigators, study teams, and stakeholders to assist in writing and developing clear, scientifically sound clinical trial protocols, ensuring adherence to regulatory guidelines and internal policies. Guide investigators on protocol design elements to ensure acceptability to regulators and ethical considerations. Prepare and submit documentation to Institutional Review Boards (IRBs) for initial study approval, amendments, continuing reviews, and other required reports. Serve as the primary point of contact for IRB communications, addressing queries in a timely manner. Review trial summary reports and ensure quality of data abstractions by cross-checking data and verifying contracts from source documents for accuracy. Qualifications
Minimum Education and Experience: Master's Degree in Regulatory Affairs plus a minimum of three (3) years of experience in a clinical research, healthcare, or higher education environment, with focus on research, regulatory, clinical trials, and/or FDA submission experience. Experience in preparing and managing FDA submissions is required. Required Knowledge, Skills, and Abilities: Detail-oriented with excellent organizational, communication, and interpersonal skills; able to maintain high professional standards and responsibly manage resources. Proficient with Microsoft Word, Excel, Access, and PowerPoint; computer literate with experience using databases and reporting tools. Preferred Qualifications: Experience assisting with clinical trial protocol and informed consent form writing is preferred. Benefits
Rutgers offers a comprehensive benefits package to eligible employees, including: Medical, prescription drug, and dental coverage Paid vacation, holidays, and various leave programs Competitive retirement benefits and savings options Employee and dependent educational benefits Life insurance coverage Employee discount programs For detailed information on benefits and eligibility, please visit: http://uhr.rutgers.edu/benefits/benefits-overview. Position Details
Position Status:
Full Time Working Hours (per week):
37.50 Work Arrangement:
This position requires a fully on-site work arrangement. Union:
HPAE 5094 Seniority Unit:
– Terms of Appointment:
Staff - 12 month Position Pension Eligibility:
ABP Posting Details
Posting Number:
25ST1841 Posting Open Date:
08/26/2025 Regional Campus:
Rutgers Biomedical and Health Sciences (RBHS) Home Location Campus:
Rutgers University - New Brunswick City/State:
New Brunswick, NJ Pre-employment and Compliance
All offers of employment are contingent upon successful completion of pre-employment screenings. Immunization policies may apply for on-site roles; vaccinations or exemptions may be required and failure to comply may rescind an offer. Affirmative Action/Equal Employment Opportunity:
Rutgers is an equal opportunity employer. We value diversity and prohibit discrimination or harassment on the basis of protected status. For more information, see the Non-Discrimination Statement: http://uhr.rutgers.edu/non-discrimination-statement
#J-18808-Ljbffr