YCCI Asst. Dir., Protocol Activation & Maintenance

29-Jan-2024

YSM Cores - YCCI

86204BR

Yale Posting Status

CLOSED TO FURTHER APPLICATIONS

University Job Title

Assistant Director, YCCI

Bargaining Unit

None - Not included in the union (Yale Union Group)

Compensation Grade

Administration & Operations

Compensation Grade Profile

Senior Manager; Senior Program Leader (27)

Wage Ranges

Click here to see our Wage Ranges

Searchable Job Family

Administration

Total # of hours to be worked:

37.5

Work Week

Standard (M-F equal number of hours per day)

Work Location

Medical School Campus

Worksite Address

221 Whitney Ave
New Haven, CT 06511

Position Focus:

Reporting to the Senior Associate Director, Strategy and Transformation Initiatives at the Yale Center for Clinical Investigation (YCCI), this position manages the development, implementation and monitoring of an effective clinical research trial activation service line for Yale School of Medicine and School of Public Health trials supported by YCCI services. The position oversees the YCCI clinical research trial activation service line and the implementation of quality control measures to promote timely trial activation and regulatory compliance with trial submission guidelines with various governing agencies and departments. A critical component of the role is to identify to the Directors best practices for streamlined and cost-effective services and recommend solutions to improve the overall operations for the safe and efficient conduct of clinical trials and educational and training opportunities for faculty and staff.

Essential Duties

1.    Leads, manages, and advises on regulatory matters as assigned. This includes: serving as an expert resource regarding applicable laws, regulations, and standards governing human subjects research conducted in the United States and other countries; providing advice and ensuring the efficient review, identification, and resolution of regulatory issues with a focus on customer service and compliance; and delivering relevant training.  2.    Leads, manages, and advises on compliance matters as assigned.  This includes leading, managing, and advising on the following: human research oversight activities (e.g., monitoring, internal and external reviews, audits, and inspections); systematic reviews that evaluate researcher and study team compliance with IRB approved protocols and applicable laws, regulations, and standards; and the oversight, investigation, and escalation of compliance issues and complaints.  3.    Leads, manages, and advises on quality matters (quality control, quality assurance, and quality improvement) as assigned. This includes leading, managing, and advising on the following: YCCI quality; post-IRB approval monitoring of research studies and other quality improvement activities; reporting and tracking of monitoring findings and reports requested from sponsors, federal agencies, and other oversight bodies; and ensuring that periodic audits of the internal and external IRBs are conducted to ensure compliance.  4.    Leads, manages, and advises on operational matters and ensures operational efficiency and compliance with laws, regulations, and standards related to the conduct of human research. This includes leading, managing, and advising on the following:  departmental and cross-departmental initiatives, projects, and requests for assistance by the University community; delivery of day-to-day service levels, customer experience, and quality measures; change management within the YCCI; collaborations with other business units; strategic objectives set forth by the YCCI and University; operational effectiveness and strategies to ensure quality and efficiency; operational opportunities, risk management, and continuous quality improvement; and verifying that institutional requirements have been satisfied.  5.    Leads, manages, and advises on relationships external to the YCCI and University as assigned. This includes: facilitating discussions with research investigators, program directors and high-ranking officials from external institutions or organizations who are interested in pursuing a collaborative research affiliate relationship with Yale University; collaborating with ancillary committees, departments, and organizations external to Yale regarding human research matters; and managing reliance and other agreements. 6.    Leads, manages, and advises on matters related to YCCI accounts receivable, billing, and financial forecasting and reporting as assigned. 7.    Leads, manages, and advises on medical and scientific matters related to human research protection program matters as assigned.8.    Other Duties as assigned.

Required Education and Experience

Bachelor’s degree; 7 years of relevant experience in research administration or human subject protection with 5 years prior monitoring experience in industry or at a large academic institution, hospital/medical center, , or non-profit organization/foundation; or an equivalent combination of education and experience.  

Required Skill/Ability 1:

Demonstrated expertise and a comprehensive understanding of applicable legal, regulatory, and medical terminology and ability to interpret, analyze, apply, and communicate (verbally and in writing) applicable ethical principles, standards, regulations, guidance, policies, and academic and industry trends that impact human research.

Required Skill/Ability 2:

Demonstrated ability to manage, organize, and execute complex projects; multi-task, identify, analyze, and resolve problems efficiently and effectively; use independent good judgment and to assess risk; and independently follow-through on tasks, develop and execute work plans, prioritize work, and manage multiple assignments to meet deadlines.

Required Skill/Ability 3:

Demonstrated ability to evaluate information, formulate logical and objective conclusions, and make recommendations for effective solutions, strategies, and approaches; and ability to distill and communicate complex information into understandable information.

Required Skill/Ability 4:

Demonstrated ability to provide guidance regarding regulatory requirements and resolve issues; proactive, flexible, and customer service focused with the ability to work effectively with others; and demonstration of ethics and integrity in professional matters, sensitivity to confidentiality, and commitment to protecting research participants.

Required Skill/Ability 5:

Demonstrated technology and software application skills; ability to learn new software packages; highly skilled in office productivity software (e.g., Word, PowerPoint, Excel, e-mail, Outlook, and Adobe, etc.); and knowledge of technology platforms used in research (e.g., IRB management, clinical trial management, and related platforms).

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.

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

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).

Note

Yale University is a tobacco-free campus