Clinical Research Coordinator

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 completeClinical 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

1. Compares protocols and sponsored projects to confirm consistency between funding proposals/awards and approved protocols. 2. Documents established congruency between funding proposals and approved protocols. 3. Facilitates and/or assists with resolution of any inconsistencies between funding proposals and approved protocols. 4. Serves as a liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner. 5. Attends meetings and presents issues when necessary that were identified during congruency review. 6. Serves as a resource and provides technical assistance to investigators and their staff. 7. Provides analytical and technical support related to establishing and recording protocol/grant congruency, as needed. 8. Monitors federal and state regulations for new guidance, updates, or policies. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure University compliance with congruency review and reporting requirements. 9. Develops, implements, and manages internal practices that ensure compliance with federal requirements. 10. May perform other duties as assigned.

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.