Clinical Research Coordinator- Neurology Epilepsy

Overview The Clinical Research Coordinator (CRC) in the Department of Neurology’s Clinical Research Office will lead coordination of an NIH‑funded study focused on seizure forecasting through longitudinal saliva sampling. The role oversees study startup, patient screening and enrollment, informed consent, coordination with the epilepsy monitoring unit and clinical teams, and management of protocol milestones. Responsibilities Lead study startup, patient screening and enrollment, and informed consent processes. Maintain study databases for screening, enrollment, withdrawals, and sample/seizure timing data. Coordinate with the collaborating site at the University of California, San Francisco and serve as primary contact for sponsor communications and regulatory documentation. Support research subjects through recruitment, consent, education, sample collection, transport, storage, monitoring, compliance, and retention. Educate clinical staff on sample collection procedures, act as main point of contact, and train participants on at‑home collection and device use. Coordinate shipment logistics for study materials, ensure proper handling and transport of biospecimens, and monitor freezer temperatures for sample integrity. Assist with protocol amendments, renewals, and oversight of the human subjects research protocol. Monitor federal and state regulations, ensuring compliance with human subjects research and reporting requirements. Develop, implement, and manage standard operating procedures aligned with state and federal requirements. Travel locally within Connecticut and perform occasional evening/weekend coverage as required. Perform other duties as assigned. Required Skills and Abilities Proven experience obtaining informed consent and interacting with research participants; professional, patient‑centered approach. Demonstrated attention to study requirements, regulatory compliance, and accuracy in follow‑through; experience with IRB and regulatory submissions. Excellent verbal and written communication, strong organization and time‑management; ability to prioritize competing tasks. Independence, critical thinking, and problem‑solving skills to ensure effective study execution and sponsor compliance. Exceptional time and attendance; flexibility to attend study needs, subject recruitment, and teamwork with other coordinators. Preferred Education, Experience and Skills Bachelor’s degree in a health or research‑related discipline and at least three years of similar work experience. Ability to work independently under minimal supervision within a team environment. Familiarity with neurological clinical research. Experience with EPIC and OnCore systems and IRB submissions. Proficiency with office software and databases for documenting clinical research data. Preferred Licenses or Certifications Certified Clinical Research Professional (CCRP) or equivalent. Principal Responsibilities Compare protocols and sponsored projects to confirm consistency between funding proposals/awards and approved protocols. Document established congruency between funding proposals and approved protocols. Facilitate and/or assist with resolution of any inconsistencies between funding proposals and approved protocols. Serve as liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues promptly. Attend meetings and present issues identified during congruency review. Serve as a resource and provide technical assistance to investigators and their staff. Provide analytical and technical support related to establishing and recording protocol/grant congruency. Monitor federal and state regulations for new guidance, updates, or policies and maintain up‑to‑date knowledge. Develop, implement, and manage internal practices that ensure compliance with federal requirements. Perform other duties as assigned. Background Check Requirements All candidates will be subject to pre‑employment background screening, including motor vehicle, DOT certification, drug testing, and credit checks as appropriate. Offers are contingent upon successful completion of the background check. Health Requirements This is a healthcare worker position. Candidates must meet health requirements including MMR, varicella, TB screening, COVID, hepatitis B and annual flu vaccination. Equal Employment Opportunity The University is committed to basing judgments concerning the admission, education, and employment of individuals upon their qualifications and abilities and seeks to attract a diverse population. Yale does not discriminate on the basis of sex, sexual orientation, gender identity, race, color, national or ethnic origin, religion, age, disability, veteran status, or other protected categories. Note Yale University is a tobacco‑free campus. #J-18808-Ljbffr