Clinical Research Coordinator

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Overview

The mission of the Fucito Lab at Yale is to reduce the public health burden of substance use. We aim to achieve this goal through innovative clinical research: 1) studies of factors that promote use, characterize unique risk profiles, and identify novel intervention targets, 2) studies that develop and test effective strategies that reduce substance use and related harm, 3) obtain scientific evidence to inform policy and healthcare implementation.

The lab is currently conducting 4 large-scale clinical research studies with a primary focus on either tobacco use and cessation or alcohol use disorder risk. Studies include 2 randomized trials to test medications for vaping cessation and nicotine vapes or pouches for smoking cessation, a combined randomize trial and neuroimaging study of sleep interventions for smoking or vaping cessation, and a national, 12-month observational study of alcohol risk in young adults. Research studies make extensive use of technology such as wearable devices, smartphone applications, text messaging, social media, electronic health records, and web-based platforms such as Qualtrics, REDCap.

Primary duties include managing the daily operations under the direction of the PI, ensuring adherence to protocols, regulatory standards, and good clinical practice guidelines, and overseeing the daily work of research staff (RAs, PGAs, student interns working in the lab). The CRC may participate in recruitment, informed consent, screening, and scheduling visits, ensuring timely and appropriate collection of study data, by research staff, data management, preparing DSM reports, IRB amendments and clinical trials.gov updates.

Other primary duties include managing recruitment contracts and procedures, administering standardized interviews and questionnaires to participants, and onboarding participants to technology. The CRC is responsible for maintaining research records, including source documents and case report forms, entering data into electronic data capture systems, reporting adverse events, providing sponsors with requested clinical and regulatory information, and resolving data queries in a timely manner. Laboratory responsibilities may include coordinating laboratory specimen collection, storage, and shipment and maintaining laboratory equipment and supplies. Other responsibilities include onboarding, training, and supervision of new staff, managing study supplies and expenses, and supporting medication orders in collaboration with the Investigational Drug Service, and assisting with monitor visits. The Manager may also be asked to assist with the preparation of research protocols, and protocol renewals and amendments for submission to the investigational review board (IRB).

Required Skills and Abilities
1. Clinical Research Proficiency and Compliance. Proven experience with clinical studies. Ability to complete Clinical trials recruitment, consenting and data collection. Ability to conduct research interviews.
2. Self-Motivation, Organization, and Detail-Orientation. Demonstrates self-motivation, independence, consistency, and reliability. Shows excellent attendance, punctuality, and organizational skills. Pays excellent attention to detail and communicates effectively.
3. Technical Proficiency: Exhibits proficiency in Microsoft Office, Experience with electronic data collection tools such as iPads, smartphone applications, platforms like REDCap, Qualtrics, or electronic health record systems like EPIC.  Facility with other technology such as wearable devices.
4. Effective Under Pressure with Communication and Leadership. Proven ability to work efficiently and independently under pressure, prioritizing tasks effectively. Demonstrates strong oral and written communication skills, along with leadership qualities. Experience supervising students/others.

Preferred Skills and Abilities:

Experience with Psychiatric or substance abuse research. Experience with REDCap, Qualitrics, smart phone applications, and wearable devices. Experience with biosamples.

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.