Clinical Research Coordinator- Neurology Epilepsy

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Overview

The Clinical Research Coordinator (CRC), within the Department of Neurology’s Clinical Research Office and reporting to the Associate Director of Clinical Research will lead coordination of an NIH-funded study focused on seizure forecasting through longitudinal saliva sampling. Responsibilities include study startup, patient screening and enrollment, informed consent, coordination with the epilepsy monitoring unit and clinical teams, and management of protocol milestones.

The CRC will have direct patient contact and oversee day-to-day study operations, including maintaining study databases (screening, enrollment, withdrawals, and sample/seizure timing data). The role includes coordination with a collaborating site at the University of California, San Francisco, and serving as a primary contact for sponsor communications and regulatory documentation.

Some responsibilities may require occasional evening/weekend coverage and local travel within Connecticut. This work aims to develop novel biomarkers for seizure forecasting, with potential to directly improve patient safety and quality of life.

Please disregard the Principal responsibilities below focus on the Overview.

Interact directly with research subjects and research staff to support the study, including recruitment, consent, education, sample collection, sample transportation, sample storage, monitoring, compliance, and retention.

Educate clinical staff on sample collection, meet with them regularly, and serve as their main contact for questions. Actively participate in sample collection, as needed.

Coordinate shipment logistics for study materials (e.g., collection kits, wearables, freezers). Train participants on at-home sample collection, storage, and device use. Ensure proper handling and transport of biospecimens to Yale. 

Visit study participants’ homes to set up freezers and provide training on proper sample collection and storage when necessary.

Ensure sample collection freezers and wearables are functioning, sanitized before dispatch, and safely transported.

Ability to transport equipment and travel locally as required.

Monitor and log freezer temperatures for sample integrity.  

Maintain accurate records of study participants, collected samples, and metadata related to the project.

Assist with amendments, renewals, and oversight of the human subjects research protocol.

Monitor relevant federal and state regulations and ensure compliance with human subjects research and reporting requirements.

Develop, implement, and manage standard operating procedures that ensure compliance with state and federal requirements related to the project.

May perform other duties as assigned.

Required Skills and Abilities

1. Proven experience obtaining informed consent and interacting with research participants. Ability to collaborate effectively with clinical teams, track study activities, and document outcomes accurately and in a timely manner. Professional and patient-centered approach.

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. Proven eperience with the IRB and knowledge about IRB processes (study amendments, protocol updates).

3. Excellent verbal and written communication skills with strong organizational and time management abilities. Demonstrated ability to independently prioritize competing tasks and deadlines.

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. Bachelor’s degree in health or research related discipline and three 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.

5. Proven experience with the use of office software and databases for documenting clinical research data.

Preferred Licenses or Certifications

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

Principal Responsibilities

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.

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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.