"Clinical Programs Coordinator"

Overview

The Clinical Programs Manager will oversee and coordinate key clinical initiatives within the Department of Ophthalmology and Visual Science, with a primary focus on managing the department’s clinical trial programs and leading the coordination of the Retinopathy of Prematurity (ROP) program. This position serves as a central resource for coordinating all aspects of the clinical research operations and programmatic alignment, ensuring that both clinical trials and ROP coordination activities are conducted efficiently, in compliance with institutional and regulatory standards, and in collaboration with faculty, research staff, hospital partners, and external stakeholders.

Job Duties

• Carries out research within the scope of the established study protocol. Adheres to all human subjects regulations as defined by Yale University and the federal government that pertain to research studies.
• Develops criteria for admission of study subjects based on goals and objectives of project.
• Determines potential sources of funding and prospective partnerships.
• Evaluates feasibility of accepting potential projects through analysis of staffing needs, resource requirements, financial costs, and current planned capacity of group. Negotiates contracts and/or changes with funder.
• Develops original HIC/IRB submissions. Based on knowledge of science and research goals, collaborates with PIs on major revisions and contributes to scientific protocols. Plans and implements changes.
• Develops forms, questionnaires and the application of research techniques; writes procedures manuals for data collection and coding.
• Responsible for the documentation and transmission of study data. Ensures that report forms are accurately documented and completed in a timely manner at each site location.
• Works independently to develop manage and organize multi site studies. Serves as primary coordinator between University, non-Yale collaborators, pharmaceutical companies, HIC, IRB and funding sources.
• Performs descriptive and multivariate statistical analyses of data, using computer software.
• Designs and implements quality control measures to ensure accurate collection and processing of data. Contributes in-depth, original thought and relevance to written reports and to the writing of abstracts and manuscripts.

Required Skills and Abilities

1. Demonstrated experience managing or coordinating clinical trials, Strong knowledge of clinical research regulations, GCP, and IRB processes with proven experience.
2. Demonstrated ability obtaining informed consent. Proven ability to manage multiple concurrent projects with complex workflows and competing deadlines.
3. Excellent organizational, leadership, and communication skills with the ability to work collaboratively across disciplines.
4. Proficiency in Microsoft Suite, data management and documentation systems related to clinical research or patient coordination.
5. Proficiency with institutional systems such as OnCore, Workday, and Epic, or equivalent research and clinical management platforms.

Preferred Skills and Abilities

1. Familiarity with patient recruitment processes, data management, and statistical analysis software.
2. Prior involvement with Retinopathy of Prematurity (ROP) screening or neonatal ophthalmology coordination strongly preferred.
3. Certification in clinical research coordination or management.

Principal Responsibilities

1. Carries out research within the scope of the established study protocol. Adheres to all human subjects regulations as defined by Yale University and the federal government that pertain to research studies.
2. Develops criteria for admission of study subjects based on goals and objectives of project.
3. Determines potential sources of funding and prospective partnerships.
4. Evaluates feasibility of accepting potential projects through analysis of staffing needs, resource requirements, financial costs, and current planned capacity of group. Negotiates contracts and/or changes with funder.
5. Develops original HIC/IRB submissions. Based on knowledge of science and research goals, collaborates with PIs on major revisions and contributes to scientific protocols. Plans and implements changes.
6. Develops forms, questionnaires and the application of research techniques; writes procedures manuals for data collection and coding.
7. Responsible for the documentation and transmission of study data. Ensures that report forms are accurately documented and completed in a timely manner at each site location.
8. Works independently to develop manage and organize multi site studies. Serves as primary coordinator between University, non-Yale collaborators, pharmaceutical companies, HIC, IRB and funding sources.
9. Performs descriptive and multivariate statistical analyses of data, using computer software.
10. Designs and implements quality control measures to ensure accurate collection and processing of data.
11. Contributes in-depth, original thought and relevance to written reports and to the writing of abstracts and manuscripts.

Required Education and Experience

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