Coordinator, Research Support

Overview

The Veterans Health Administration (VHA) Headache Centers of Excellence (HCoE) is a national network of 28 sites dedicated to improving access, quality, and outcomes for Veterans for the more than 2 million Veterans living with headache and migraine through coordinated clinical innovation, education, quality improvement (QI), and research. The HCoE partners closely with academic institutions (including Yale University, Yeshiva University, Brown University, Harvard University), medical centers (including Mayo Clinic, U.S. Department of Defense) federal funders (including the National Institutes of Health [NIH], Patient Centered Outcomes Research Initiative [PCORI]), the Unites States Congress, and Veteran stakeholders to design, implement, and evaluate interventions that can be scaled across VA facilities nationwide.

To support the HCoE’s expanding portfolio of NIH- and PCORI-funded multi-site studies and multi-site QI/implementation initiatives, we are seeking two experienced professional who can operate independently, manage a portfolio of parallel initiatives (typically 5-15 sites per initiative), coordinate cross-HCoE core activities (e.g., Education, Innovations, Pharmacology, Non-Pharmacologic), build durable operational and data systems, ensure regulatory and safety-monitoring readiness, and serve as a primary liaison with funders (NIH/PCORI), Yale, VA partners, and the HCoE Veteran Engagement Workgroup.

This is a hybrid position working a minimum of three days on campus at the VA- Orange , CT location. With occasional travel to other CT sites.

Responsibilities

• Serves as a liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner.
• Carries out research within the scope of established study protocols. Adheres to all human subject 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.
• 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 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, VHA, non-Yale collaborators, IRBs, funding sources, and other organizations.
• 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.
• Compares and documents protocols and sponsored projects to confirm consistency between funding proposals/awards and approved protocols.
• Monitors federal and state regulations for new guidance, updates, or policies. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure University compliance with congruency review and reporting requirements.
• Develops, implements, and manages internal practices that ensure compliance with federal requirements.
• May perform other duties as assigned.

Required Skills and Abilities

1. Proven experience obtaining informed consent. Excellent written and verbal communication skills, with strong attention to detail.
2. Proven experience conducting and supporting all phases of clinical and operational research (clinical trials and multi-site data collection).
3. Advanced skills in data management and quantitative analysis, strong Excel is a must.
4. Strong organizational skills, with the ability to multitask, prioritize tasks, and manage time effectively.
5. Demonstrated ability to work both independently and as part of a multidisciplinary team. Proficiency in Microsoft Office Suite and experience with electronic data collection tools.

Preferred Skills and Abilities

1. Advanced skills in VHA data management (e.g., SQL) or previous experience working with the VHA’s Corporate Data Warehouse (CDW). Proven experience with tools like REDCap, SAS, or R and/or advanced skills in qualitative data management and analyses, including use of tolls like Nvivo or Atlas.ti.
2. Proven experience working with federal regulations and VHA IRBs (e.g., HIPAA), particularly in the context of sensitive documents containing PHI/PII.
3. Ability to work with minimal supervision in a team atmosphere and receptiveness to direction. Demonstrated skill in meticulous attention to study requirements, regulatory constraints, and accurate follow-through. Ability to prepare and submit regulatory documents and maintenance requirements for the life of the trial(s).
4. Thoroughly skilled in monitoring multi-site research subject recruitment and interactions. Able to prepare documentation for informed consent and related research subject interactions and requirements. Proven ability to track multiple occurrences and outcomes and document the same in a timely manner. Exceptional organizational skills.
5. Demonstrated independence and management skills among multiple study sites. Demonstrated ownership of communication requirements necessary for effective oversight and conduct of human clinical research utilizing multiple electronic data capture systems.

Principal Responsibilities

1. Compares protocols and sponsored projects to confirm consistency between funding proposals/awards and approved protocols.
2. Documents established congruency between funding proposals and approved protocols.
3. Facilitates and/or assists with resolution of any inconsistencies between funding proposals and approved protocols.
4. Serves as a liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner.
5. Attends meetings and presents issues when necessary that were identified during congruency review.
6. Serves as a resource and provides technical assistance to investigators and their staff.
7. Provides analytical and technical support related to establishing and recording protocol/grant congruency, as needed.
8. Monitors federal and state regulations for new guidance, updates, or policies. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure University compliance with congruency review and reporting requirements.
9. Develops, implements, and manages internal practices that ensure compliance with federal requirements.
10. May perform other duties as assigned.

Required Education and Experience

Bachelor’s degree in a relevant academic/scientific field and a minimum of 3 years of related research support experience; or the equivalent combination of education or experience.