Clinical Research Coordinator 1

Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community, eligible for opportunities through the New Haven Hiring Initiative, or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale! Overview The Clinical Research Coordinator I (CRC I) is responsible for providing research services to patients participating in clinical trials within the Yale Emergency Department. The CRC I will ensure safe, compliant, efficient, and effective conduct of acute care clinical trials. Key responsibilities include overseeing, planning, tracking, and ensuring that the clinical activities for study participants are conducted in accordance with approved protocols, including patient screening, eligibility determination, registration, and other protocol and subject milestones. The position works within a multidisciplinary environment with colleagues both internally and externally in a cooperative manner exercising respectfulness and professionalism. The CRC I will have direct patient contact and is responsible for managing and performing the clinical and operational aspects of low to moderately complex clinical trial and observational patient–related trials. Responsibilities Serve as the primary oversight specialist on clinical and operational processes for low to moderately complex studies in the emergency department. Manage, implement, and evaluate all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration for low to moderately complex studies. Oversee the maintenance of accurate documentation, recruitment of study participants, and ensure regulatory and protocol requirements and guidelines are met per IRB, federal regulation, and institutional and sponsor requirements. Analyze, document and convey study data on low to moderately complex clinical trials to ensure that report forms are accurately documented and completed in a timely manner. Oversee the tracking and reporting of adverse events, serious adverse events, protocol waivers, deviations, and violations in coordination with the study PI. Participate in interim monitoring visits and internal audits. Monitor, interpret, and communicate federal and state regulations, and local policies for new guidance, updates, or policies. Participate in secondary analyses of primary data collection in collaboration with study teams. Participate in abstract, manuscript and proposal preparation as outlined by the PI. Perform other duties as assigned. Required Skills and Abilities Strong organizational skills that allow for multi-tasking, prioritizing emergent study needs, maintaining accurate and up-to-date study logs/documents, and ensuring adherence to study protocol. Familiarity with emergency care research and cardiac arrest outcomes. Most studies will warrant nuanced understanding of eligibility and clinical parameters for enrollment. Prior experience in acute care research and/or clinical exposure will be beneficial. Strong interpersonal skills required. Working with a varied team of scientists, physicians, nurses, and emergency technicians requires the ability to communicate and interact in a busy emergency department. Acute care research also entails dealing with patients and families under significant duress. Expressing empathy, patience, and prioritizing team collaboration is essential. Writing skills in scientific preparation of research abstracts and manuscripts. Additional primary authorship roles are possible, if desired, but writing support will be requisite. Flexibility is key. Emergency care research requires some element of flexibility as patients present at all times of day/night. In the CRC I role, there is an expectation of study ownership and potential for off‑hours work that will be kept to a minimum and will be accounted for in weekly hour requirements. Principal Responsibilities Serve as the primary oversight specialist on clinical and operational processes for low to moderately complex studies and non‑therapeutic trials. Serve as a supporting clinical research coordinator to CRC/CRN II and Sr. CRC/CRN for highly complex protocols. Manage, implement, and evaluate all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration for low to moderately complex studies and non‑therapeutic trials. Contribute to study feasibility reviews and make recommendations based on analysis of the protocol and knowledge of clinical trials, operations, and ICH/GCP, federal regulation, and institutional processes for low to moderately complex clinical trials and non‑therapeutic trials. Ensure low to moderately complex study protocols are adhered to, oversee the maintenance of accurate documentation, recruitment of study participants, and ensure regulatory and protocol requirements and guidelines are met per ICH/GCP, federal regulation, and institutional and sponsor requirements. Identify instances of noncompliance and deviations from protocol and work with manager to analyze and advise noncompliance and deviations to the appropriate parties. Advise Principal Investigator oversight on low to moderately complex clinical trials and non‑therapeutic trials by providing updates on protocol issues, status of signatures and clinical significance on lab reports, ECGs, adverse events and other documents as required. Analyze, document and convey study data on low to moderately complex clinical trials and non‑therapeutic trials. Coordinate with assigned staff to oversee and ensure that report forms are accurately documented and completed in a timely manner. Oversee the tracking and reporting of adverse events, serious adverse events, protocol waivers, deviations, and violations on low to moderately complex clinical trials and non‑therapeutic trials. Assess trial execution for assigned low to moderately complex trials and non‑therapeutic trials and identify areas that need improvement or that require correction and provide education and/or recommendations, as needed. Collaborate with Investigators and Research Managers in the preparation and execution of corrective and preventative action plans and ensure implementation and adherence to stated plan for low to moderately complex trials and non‑therapeutic trials. Collaborate with the Quality Education Unit to contribute to the design of CRC trainings and continuing education. Participate in interim monitoring visits and internal audits. Monitor, interpret, and communicate federal and state regulations, and local policies for new guidance, updates, or policies. Perform other duties as assigned. Required Education and Experience Bachelor’s degree in a health‑related discipline, or other related field, and one (1) year of clinical research experience, or the equivalent combination of education or experience. Knowledge of Good Clinical Practices (GCP) and Federal Regulations is required. Experience must indicate the ability to work with minimal supervision in a team environment. Health Requirements This role is a healthcare worker position. Healthcare workers (HCW) are defined as university employees working in 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. Equal Employment Opportunity Statement 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). #J-18808-Ljbffr