Address
Form of workEssential Duties
1. Creates and maintains Delegation Task Log and study rosters for studies sponsored by the National Cancer Institute (NCI), as directed. 2. Monitors and communicates relevant updates to appropriate Regulatory Affairs Specialists from the Cancer Trials Support Unit (CTSU) website. 3. Collects and monitors required research training certifications and other study personnel documents and credentials for investigators and study team members. 4. Prepares regulatory documents for clinical trials, as directed. 5. Maintains central trackers and logs and ensures accurate entry and distribution to study teams in a timely manner. 6. Assists with tracking and follow up on essential regulatory study documents, as directed. 7. Coordinates clean up, archiving, and reconciliation of study files, as directed. 8. May perform other duties and responsibilities as assigned or directed by the supervisor.
Required Education and Experience
Two years of related work experience in the same job family and a Bachelor's degree in a related field; or an equivalent combination of experience and education.
Background Check Requirements
All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.
Position Focus:
This is a remote position within CT.
Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute (NCI). Yale Cancer Center delivers the highest quality patient-centered care, achieves breakthrough discoveries, and trains the future leaders in cancer science and medicine. There are over 300 clinical trials providing the most advanced cancer therapies at Smilow Cancer Hospital and in the 15 Care Centers, and trials are available within 20+ disease units. Yale has been at the forefront of understanding the fundamental mechanisms of cancer biology and in developing effective therapies for the treatment of cancer, and harnesses the resources of the Yale School of Medicine and Smilow Cancer Hospital at Yale-New Haven to advance cancer research, prevention, and patient care, as well as community outreach and education. Reporting to the Regulatory Affairs Manager, the Regulatory Assistant provides Regulatory Affairs support with administrative maintenance and follow-up for the Yale Cancer Center (YCC) Clinical Trials Office (CTO). Responsibilities include, but are not limited to, , tracking and maintenance of staff credentials and training documents and assistance with regulatory document preparation and tracking. . Please refer to the Essential Duties below for a full scope of the job duties.
Preferred Education, Experience and Skills:
Prior experience with research-related regulatory documentation. Oncology experience is a plus. Administrative or clinical experience in a healthcare setting is desirable. Other helpful experience includes maintaining complex trackers and documents in databases, and advanced MS Office and technology skills.
Posting Disclaimer
The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position. Employees will be assigned specific job-related duties through their hiring departments.
EEO Statement:
University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans. Additionally, in accordance with Yale's Policy Against Discrimination and Harassment, and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual's sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.
Inquiries concerning Yale's Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).
Required Skill/Ability 2:
Ability to apply knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, institutional and sponsor practices, standards, policies, and procedures at the unit/functional level.
Required Skill/Ability 3:
Professionalism, maturity, good judgment, and ability to work with confidential material and protected health information. Excellent oral, and written communication skills and ability to work effectively with a wide variety of external and internal stakeholders.
Required Skill/Ability 4:
Independent worker with ability to multi-task and remain focused in a fast-paced environment. Takes initiative to support the regulatory component of complex studies across the study lifespan. Works under minimal supervision and understands when to inform others of developments or issues with a specific study.
Required Skill/Ability 5:
Organized, analytical, with a high attention to detail to complete assignments. Decisions are guided by various factors including experience, context, and team collaboration.
COVID-19 Vaccine Requirement
The University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here:
https://covid19.yale.edu/health-guidelines
1. Creates and maintains Delegation Task Log and study rosters for studies sponsored by the National Cancer Institute (NCI), as directed. 2. Monitors and communicates relevant updates to appropriate Regulatory Affairs Specialists from the Cancer Trials Support Unit (CTSU) website. 3. Collects and monitors required research training certifications and other study personnel documents and credentials for investigators and study team members. 4. Prepares regulatory documents for clinical trials, as directed. 5. Maintains central trackers and logs and ensures accurate entry and distribution to study teams in a timely manner. 6. Assists with tracking and follow up on essential regulatory study documents, as directed. 7. Coordinates clean up, archiving, and reconciliation of study files, as directed. 8. May perform other duties and responsibilities as assigned or directed by the supervisor.
Required Education and Experience
Two years of related work experience in the same job family and a Bachelor's degree in a related field; or an equivalent combination of experience and education.
Background Check Requirements
All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.
Position Focus:
This is a remote position within CT.
Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute (NCI). Yale Cancer Center delivers the highest quality patient-centered care, achieves breakthrough discoveries, and trains the future leaders in cancer science and medicine. There are over 300 clinical trials providing the most advanced cancer therapies at Smilow Cancer Hospital and in the 15 Care Centers, and trials are available within 20+ disease units. Yale has been at the forefront of understanding the fundamental mechanisms of cancer biology and in developing effective therapies for the treatment of cancer, and harnesses the resources of the Yale School of Medicine and Smilow Cancer Hospital at Yale-New Haven to advance cancer research, prevention, and patient care, as well as community outreach and education. Reporting to the Regulatory Affairs Manager, the Regulatory Assistant provides Regulatory Affairs support with administrative maintenance and follow-up for the Yale Cancer Center (YCC) Clinical Trials Office (CTO). Responsibilities include, but are not limited to, , tracking and maintenance of staff credentials and training documents and assistance with regulatory document preparation and tracking. . Please refer to the Essential Duties below for a full scope of the job duties.
Preferred Education, Experience and Skills:
Prior experience with research-related regulatory documentation. Oncology experience is a plus. Administrative or clinical experience in a healthcare setting is desirable. Other helpful experience includes maintaining complex trackers and documents in databases, and advanced MS Office and technology skills.
Posting Disclaimer
The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position. Employees will be assigned specific job-related duties through their hiring departments.
EEO Statement:
University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans. Additionally, in accordance with Yale's Policy Against Discrimination and Harassment, and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual's sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.
Inquiries concerning Yale's Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).
Required Skill/Ability 2:
Ability to apply knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, institutional and sponsor practices, standards, policies, and procedures at the unit/functional level.
Required Skill/Ability 3:
Professionalism, maturity, good judgment, and ability to work with confidential material and protected health information. Excellent oral, and written communication skills and ability to work effectively with a wide variety of external and internal stakeholders.
Required Skill/Ability 4:
Independent worker with ability to multi-task and remain focused in a fast-paced environment. Takes initiative to support the regulatory component of complex studies across the study lifespan. Works under minimal supervision and understands when to inform others of developments or issues with a specific study.
Required Skill/Ability 5:
Organized, analytical, with a high attention to detail to complete assignments. Decisions are guided by various factors including experience, context, and team collaboration.
COVID-19 Vaccine Requirement
The University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here:
https://covid19.yale.edu/health-guidelines
