Clinical Research Coordinator 1

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 1 will be charged with ensuring 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. These activities include but are not limited to the oversight of 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.

1. Serves as the primary oversight specialist on clinical and operational processes for low to moderately complex studies in the emergency department.
2. Manages, implements, and evaluates all aspects of clinical trial conduct including study initiation, execution/maintenance, completion, and administration for low to moderately complex studies.
3. Oversees the maintenance of accurate documentation, recruitment of study participants and ensures regulatory and protocol requirements and guidelines are met per IRB, federal regulation, and institutional and sponsor requirements.
4. Analyses, documents and conveys study data on low to moderately complex clinical trials to ensure that report forms are accurately documented and completed in a timely manner.
5. Oversees the tracking and reporting of adverse events, serious adverse events, protocol waivers, deviations, and violations on low to moderately complex clinical trials in coordination with study PI.
6. Participates in interim monitoring visits and internal audits.
7. Monitors, interprets, and communicates federal and state regulations, and local policies for new guidance, updates, or policies.
8. Participates in secondary analyses of primary data collection in collaboration with study teams.
9. Participates in abstract, manuscript and proposal preparation as outlined by the PI.
10. Performs other duties as assigned.

Required Skills and Abilities

1. 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.
2. 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.
3. Strong interpersonals skills will be requisite. Working with a varied team of scientists, physicians, nureses and emergency technicians requires 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.
4. In addition to daily research necessities, this position will also require writing skills in scientific preparation of research abstracts and manuscripts. Additional primary authorship roles are possible, if desired, but writing support will be requisite.
5. Flexibility is key. Emergency care research requires some element of flexibility as patients present at all times of day/night. In the CRC1 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 weeklly hour requirements.