Clinical Research Coordinator - NORSE

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Overview

Within the Department of Neurology’s Clinical Research Office and reporting to the Research Manager, the Clinical Research Coordinator (CRC) will lead coordination of the Yale NORSE and VA NORSE studies, focused on New-Onset Refractory Status Epilepticus (NORSE), including FIRES. These are complex, multicenter clinical research initiatives involving acute neurocritical care populations, longitudinal follow-up, and biospecimen collection. The CRC will be responsible for end-to-end study execution, including study start-up, patient screening, eligibility determination, informed consent, enrollment, and follow-up. The CRC will serve as the primary point of contact for study operations and will manage all study documentation, regulatory submissions, and cross-site coordination. This role requires direct patient interaction in both inpatient and outpatient settings, including time-sensitive recruitment in critical care environments. The CRC will coordinate clinical data collection, biospecimen processing and shipment, and ensure protocol adherence and regulatory compliance across Yale and VA sites, as well as collaborating national and international centers. Subjects will primarily be recruited at the New Haven campus, with potential coordination across additional Yale Neurology locations and VA-affiliated sites. Some studies may require flexibility, including occasional evening or weekend coverage based on recruitment needs. Weekend Hours Required- Occasional.

Evening Hours Required- Occasional.

• Coordinate patient recruitment, enrollment, informed consent, and follow-up visits.

• Collect and manage clinical data and maintain accurate study records.

• Coordinate biospecimen collection, processing, and shipment.

• Maintain IRB/regulatory documentation and ensure audit readiness.

• Serve as liaison across investigators, clinical teams, VA partners, and collaborators.

• Ensure compliance with study protocols, GCP, and federal/VA regulations.

• Support data quality, study tracking, and reporting.

Congruency & Compliance

• Ensure alignment between protocols and funding/award documents.

• Document and resolve protocol–grant inconsistencies.

• Liaise with Grants & Contracts and study teams on compliance issues.

• Monitor regulatory updates and maintain institutional compliance processes.

• Perform other duties as assigned.

Required Education and Experience

• Clinical Research Coordinator experience.

• Biospecimen handling experience.

• Familiarity with EPIC/REDCap.

• Experience with regulatory documentation and audits.

• Background in neurology or complex clinical populations.

Required Skills and Abilities

1. Excellent verbal and written communication skills, with demonstrated outstanding organizational and time management skills. Ability to independently prioritize tasks with competing deadlines and priorities.

2. Demonstrated skill in careful attention to study requirements, regulatory compliance and accuracy in follow through. Ability to prepare and submit regulatory documents and maintenance documents for the life of the research study/trial.

3. Skilled in obtaining informed consent and related research subject interactions and requirements, including working with clinical providers to support the study. Proven ability to track multiple occurrences and outcomes and document in a timely manner.

4. Demonstrated independence and management skills including critical thinking and problem solving to ensure effective study execution and compliance with sponsor policies.

5. Exemplary time and attendance. Ability to be flexible in schedule to attend to study needs and subject recruitment and work as a team with other clinical research coordinators.

Preferred Education, Experience and Skills

1. Master’s degree in health or research related discipline and two years of related work experience in a similar job family.

2. Strongly prefer candidates with a demonstrated ability to work with minimal supervision in a team atmosphere and receptiveness to direction and new processes.

3. Familiarity with neurological clinical research strongly preferred.

4. Proven experience in EPIC and OnCore systems and IRB submissions.

Preferred Licenses or Certifications

1. Certified Clinical Research Professional (CCRP) or equivalent.

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.

Job Posting Date

04/27/2026

Job Category

Manager

Bargaining Unit

NON

Compensation Grade

Administration & Operations

Compensation Grade Profile

Supervisor; Senior Associate (23)

Salary Range

$65,000.00 - $101,000.00

Time Type

Full time

Duration Type

Staff Fixed Duration (Fixed Term)

Work Model

On-site

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.

Health Requirements

This role is a healthcare worker position. Healthcare workers (HCW) are defined as university employees working a healthcare setting who have the potential for direct or indirect exposure to patients, human research subjects or infectious materials including body substance, contaminated medical supplies, devices and equipment, surfaces, or air. HCW have specific health requirements that must be met prior to starting work, including MMR vaccine or immunity, varicella (chickenpox) vaccine or immunity, TB screening, COVID vaccine according to University policy, hepatitis B vaccine or immunity, and annual flu vaccination.

Posting Disclaimer

Salary offers are determined by a candidate’s qualifications, experience, skills, and education in relation to the position requirements, along with the role’s grade profile and current internal and external market conditions.

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 position. Employees will be assigned specific job-related duties through their hiring department.

The University is committed to basing judgments concerning the admission, education, and employment of individuals upon their qualifications and abilities and seeks to attract to its faculty, staff, and student body qualified persons from a broad range of backgrounds and perspectives. In accordance with this policy 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.