Clinical Research Coordinator 1

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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. 

 

Principal Responsibilities

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.

Required License(s) or Certification(s)

Required License(s) or Certification(s):

Physical Requirements

Physical Requirements:

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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.