Program Manager

16-May-2024

Internal Medicine - Pulmonary

88638BR

University Job Title

Research Associate 3, HSS

Bargaining Unit

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

If Fixed Duration, Period

8 months from date of hire

If Fixed Duration, is continuation possible?

Yes

Other Fixed Duration Date

14-May-2024

Compensation Grade

Clinical & Research

Compensation Grade Profile

Research Associate 3 HSS (25)

Wage Ranges

Click here to see our Wage Ranges

Searchable Job Family

Research Res Support, Research/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

15 York Street
New Haven, CT 06510

Position Focus:

The ILD Research Program Manager is a professional member of the Interstitial Lung Disease (Yale ILD) team and is responsible for the efficient, safe, and high quality conduct of clinical trials research.  Responsible for all aspects of regulatory work, subject recruitment, study visit preparation, and study activities, in compliance with University, State and, Federal guidelines.  Supervises clinical research including clinical studies (translational, epidemiological), clinical trials (investigator-initiated and pharmaceutical company -sponsored).  Participates in planning, data collection and data analysis for multi-faceted research projects.  Analyzes and evaluates clinical data gathered during research and ensures compliance with protocol and overall clinical objectives.

Essential Duties

1. Supervises research within the scope of established study protocol. Adheres to all human subjects regulations as defined by Yale University and the federal government that pertain to research studies. 2. Responsible for reviewing, planning, and implementing study protocols and assessing the impact of program changes on research quality. Identifies and makes initial contact with potential funding sources to secure funds. 3. Oversees the planning of large multi-site or global studies. Establish goals and objectives, training requirements, productivity goals and financial parameters. Develops forms and questionnaires and manages the application of research techniques. 4. Works closely with research faculty and collaborators to identify quality and operational strategies and aspects of study that need to overcome. 5. Fosters and maintains cooperative relationships with principal investigators, collaborators, study coordinators, government officials, international partnerships, and study sponsors to ensure for the safe and timely progression of studies and adherence to all study/agency/government regulations. 6. Develops original HIC/IRB submissions for multi site research. Collaborate with various PI on major revisions and ensure changes are incorporated at each participating site. 7. Uses advanced statistical knowledge to provide support in managing and analyzing data. 8. Develops operational procedures for the collection, editing, verification and management of statistical data. Develops and implements relevant statistical programs to incorporate data from multiple projects. Designs comprehensive and rational databases with advance knowledge of the scientific applications impacting on the data analyses and reporting. 9. Develops protocols for collection of data. Designs data gathering instruments and related procedures. Tests, refines and finalizes instruments for use in research study. 10. Presents talks, seminars or other oral presentations on the methodology and analyses used in scientific studies. 11. Composes major abstracts/publications/manuscript. 12. May perform other duties as assigned.

Required Education and Experience

Master’s Degree in a related discipline and four years of experience or an equivalent combination of education and experience.

Required Skill/Ability 1:

Strong organizational and management skills.

Required Skill/Ability 2:

Excellent communication skills, both written and verbal.

Required Skill/Ability 3:

Ability work independently and collaboratively in a team environment.

Required Skill/Ability 4:

Prior demonstrated experience in clinical trials/pharmaceutical studies.

Preferred Education, Experience and Skills:

Areas of knowledge and proven experience include but not limited to: ICH Good Practice Guidelines, FDA IND requirements, FDA clinical trials registration, reporting regulations and regulations/guidelines. Proven experience as Study Coordinator or similar role requiring interaction with health care professionals in patient care environments with challenges unique to study subject recruitment.

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