Clinical Research Manager

18-Jan-2024

Internal Medicine – Cardiology

86000BR

University Job Title

Manager 4, Clinical Research

Bargaining Unit

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

Compensation Grade

Administration & Operations

Compensation Grade Profile

Senior Manager; Senior Program Leader (26)

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

789 Howard Avenue
New Haven, CT 06519

Position Focus:

Under supervision of the Director of Imaging Core Laboratories, manages the Vascular Ultrasound Core Laboratory, including imaging analysis, well as administrative and regulatory aspects of the projects.  Designs and develops reports, policies and procedures to improve day to day efficiency of the studies, ensures that activities are performed within established protocol, and implements procedures and quality assurance standards for the studies.

Manages and conducts qualitative and quantitative vascular ultrasound imaging analyses of assigned clinical research studies. In conjunction with the PI, develops timelines and protocols. Acts as project manager in studies involving multiple sites. Oversees quality and recruitment, and responsible for organizational planning for all sites. Develops protocols for vascular ultrasound core laboratory studies. Participates in the design of conduct of study reports. Evaluates recruitment and assessment study progress on an ongoing basis.

Essential Duties

1. Manages and conducts recruitment and assessment study components of all clinical research studies. In conjunction with the PI, develops timelines and protocols. 2. Acts as project manager in studies involving multiple sites. Oversees quality and recruitment, and responsible for organizational planning for all sites. 3. Manages a team of research staff. 4. Develops protocols for sample collection and long term storage in biorepository in studies involving tissue collection. 5. Assists the PIs with budget preparation for grants, tracking of funds, and managing of subcontracts with participating sites. 6. Develops, implements procedures and data quality assurance standards and creates and maintains Manual of Operations for recruitment and assessment, and sample collection components of studies. Prepares and adjusts recruitment and assessment study plans by designing strategies and analyzing relevant data. 7. Prepares IRB submissions, annual re-approvals, and requests for amendments for the Yale IRB as well as applications to other IRBs and governing institutions involved in the studies. 8. Participates in the design of conduct of study reports. Evaluates recruitment and assessment study progress on an ongoing basis. 9. Determines subject’s eligibility and acceptability to clinical studies based on the study inclusion and exclusion criteria from screening assessments. 10. Obtains and interprets medical outcome data and clinical test results from other sources: hospitals, physicians’ office, and death certificates. 11. Establishes and implements an adverse monitoring protocol if necessary. 12. Prepares educational seminars and material to enhance staff knowledge and awareness of the purpose and value of the study. 13. Organizes retention events, including dinner and luncheon meetings. 14. May perform other duties as assigned.

Required Education and Experience

Bachelor of Science in Nursing or related field and six years of related experience or an equivalent combination of education and experience.

Required Skill/Ability 1:

Demonstrated success in supporting medical research with the ability to effectively identify opportunities for improvement in support functions. Demonstrated ability at a leadership/managerial level in clinical practice. Excellent management and organization skills to manage clinical practice.

Required Skill/Ability 2:

Excellent oral, interpersonal, and written communication skills. Excellent attention to detail.

Required Skill/Ability 3:

Ability to manage multiple projects and prioritize by utilizing project management tools to deliver results.

Required Skill/Ability 4:

Well-developed planning, organizational, and problem-resolution skills with the ability to continually manage project expectations with team members and key stakeholders.

Required Skill/Ability 5:

Ability to manage project teams and staff on a day-to-day basis and inspire a high level of commitment and performance.

Preferred Education, Experience and Skills:

Bachelor of Science, Radiography or Sonographer Training or related field and six years of related experience or an equivalent combination of education and experience.

Weekend Hours Required?

No

Evening Hours Required?

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

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