YCCI Clinical Research Analyst (86813BR)

University Job Title

Clinical Research Analyst 2 **

Bargaining Unit**

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

Time Type**

Full time **

Duration Type**

Regular **

Compensation Grade**

Clinical & Research **

Compensation Grade Profile**

Clinical Research Analyst 2 (24) **

Wage Ranges**

Click here to see our Wage Ranges **

Searchable Job Family**

Research Res Support **

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**

100 Church Street South

New Haven, CT 06519 **

Work Model**

Remote **

Position Focus**

As a member of the Protocol Activation and Lifecycle Management team of the Yale Center for Clinical Investigation (YCCI) and reporting to the Sr. Manager, Activation and Medicare Coverage Analysis, this position will be responsible for centralized qualifying clinical trial determinations, performing and documenting Medicare coverage analysis, and budget development as part of a unit providing comprehensive investigator support services for clinical research studies at the Yale School of Medicine. The Medicare qualifying and coverage analysis includes making and documenting the billing determinations and development of the billing grid based on the study budget. This includes reviewing research study budget requests across all disease areas along with reviewing research rate requests for laboratory or diagnostic research tests, facility services, surgical and therapeutic interventions for industry-sponsored or federally sponsored research studies. This includes investigator-initiated requests which are submitted and must be reviewed and responded to within strict timeframes. The incumbent will independently develop the budget and payment terms and directly negotiate with sponsors and/or CRO's. This position will also assist with the industry sponsored invoicing for the negotiated charges ensuring proper and timely payments based on grant /contract terms as well as internal chargebacks. **

Essential Duties**

• Works closely with investigators and other study team members including the project manager, for projects or programs of a medium to large scope to consult, conduct analysis, and identify trial objectives and requirements. 2. Interprets research business needs and translates them into application and operational requirements. Develops necessary tools and workshops to successfully elicit requirements. 3. Critically evaluates information gathered from multiple sources – research protocols, clinical trial agreements, financial budgets and fees associated with research - to reconcile conflicts, and decompose high-level information into data essentials. 4. Receives and interprets requests for data extracts, analyses, and reports. Develops reporting modules, ad-hoc reports, and related reporting tools. Conducts research, data gathering, data analysis, modeling, projecting and scenario analyses, with the aid of planning technology and databases. Develops and harnesses the data that is available to identify existing business issues and key drivers and develops solutions and initiatives. 5. Analyzes data with standard statistical methods, interprets the results, and provides written summary and reporting of data analysis. 6. Develops, validates, deploys, implements, and maintains queries for the successful extraction of appropriate data. 7. Develops and maintain documentations and libraries on key processes. 8. Assesses risk and ensures compliance with research protocols/guidelines and university procedures. 9. Determines training needs, designs, develops and conducts training sessions, meetings and conference calls with study teams and staff members. 10. Collaborates with developers and subject matter experts to establish the technical vision and analyze tradeoffs between usability and business needs. Ensures strategic and tactical plans are carried out. 11. Communicates effectively the perspective of business opportunities, needs, and risks.

Required Education And Experience

A minimum of six years of related work experience in the same job family and a Bachelor’s Degree in a related field; or an equivalent combination of education and experience. **

Required Skill/Ability 1**

Demonstrated ability in qualifying clinical trial determinations, Medicare coverage analysis development, and Pre/post award. Widespread knowledge of and ability to interpret grant financial needs while aligning the structure and content with review criteria to allow an efficient and transparent budget process resulting in favorable funding recommendations. **

Required Skill/Ability 2**

Excellent communication skills, both verbal and written, with demonstrated outstanding organizational skills. Demonstrated superior and organized customer service coordination working with faculty, corporate, federal, and/or non-profit stakeholders. **

Required Skill/Ability 3**

Extensive knowledge of federal, state or sponsor regulations and guidelines pertaining to contract and grant administration and/or expertise negotiating clinical trial language and budgets for oncology; working knowledge of the NCI guidelines **

Required Skill/Ability 4**

Ability to effectively manage personal workflow by understanding various mechanisms of time management methods. Knowledge of accounting principles and exceptional attention to detail, with well-developed organizational, analytical and problem-solving skills. **

Required Skill/Ability 5**

Ability to work well as part of a team. Ability to work well under deadline pressures without sacrificing accuracy or customer service, while handling a complex portfolio of work in an intensive multi-tasking environment. **

Preferred Education, Experience And Skills**

Previous research experience, research budget preparation, and/or grant management experience preferred. OnCore CTMS working knowledge. Must have actual experience in the preparation and management of Industry, IIT and Federally funded research. Preferred experience with Yale systems including, WorkDay, IRES, Click and Epic. **

Drug Screen**

No **

Health Screening**

No **

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**

Required

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