Full-Time

Clinical Research Coordinator

Research Support

Yale University

Yale University

Research university in New Haven, CT

Compensation Overview

$65k - $101k/yr

New Haven, CT, USA

In Person

Bachelor's

Category
Biology & Biotech (1)
Required Skills
Quality Assurance (QA)
Data Analysis
Excel/Numbers/Sheets

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Requirements
  • Proven experience with clinical studies.
  • Experience with computers, word processing, Excel, and web-based data collection such as REDCap.
  • Ability to interact successfully with patients, staff, and faculty in a clinical research and academic environment.
  • Ability to work independently and function effectively within a team.
  • Strong attention to detail, organizational skills, and the ability to prioritize and multitask.
  • 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.
Responsibilities
  • Manage, oversee, and implement multi-faceted translational research projects operated through the Stress Center in the Department of Psychiatry.
  • Serve as the primary interface between clinical and experimental studies and clinical trials in alcohol and substance use disorders.
  • Interface with university and hospital departments and collaborating research laboratories to manage subjective, biological, cognitive, and outcome specimens and clinical outcome data.
  • Recruit patients, conduct clinical diagnostic assessments, deliver interventions, and perform data management and analysis.
  • Assist the principal investigator in developing, implementing, and maintaining original research protocols and related quality assurance and study monitoring procedures.
  • Prepare manuscripts, presentations, and publications.
  • Manage research records, report adverse events, provide sponsors with requested clinical and regulatory information, and resolve sponsor issues in a timely manner.
  • Oversee laboratory specimen collection, study supplies, drug accountability, regulatory study monitoring, and monitor visits.
  • Assist with preparing research protocols, protocol renewals, and amendments for submission to the institutional review board.
  • Ensure data accuracy, create summary reports and tables, report clinical trial and FDA summary data on ClinicalTrials.gov, and create presentations.
  • Share in the training and supervision of post-baccalaureate research associates and serve as the lead coordinator of existing clinical research studies.
  • Compare protocols and sponsored projects to confirm consistency between funding proposals or awards and approved protocols.
  • Document established congruency between funding proposals and approved protocols.
  • Facilitate or assist with resolving inconsistencies between funding proposals and approved protocols.
  • Serve as a liaison between Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner.
  • Attend meetings and present issues identified during congruency review when necessary.
  • Provide technical assistance to investigators and their staff.
  • Provide analytical and technical support related to establishing and recording protocol/grant congruency.
  • Monitor federal and state regulations for new guidance, updates, or policies and maintain knowledge of these requirements to determine and follow actions needed for university compliance.
  • Develop, implement, and manage internal practices that ensure compliance with federal requirements.
Desired Qualifications
  • Bachelor's degree in a health or research-related discipline and three years of related work experience in clinical research coordination.
  • Certified Clinical Research Professional (CCRP) or equivalent certification.
  • Experience with FDA/regulatory submissions and compliance, specifically within clinical trials.
  • Advanced skills in data management and analysis, including the use of tools like REDCap, Excel, and OnCore.
  • Familiarity with neurological or multi-specialty research, with hands-on experience in patient recruitment and study management.

Yale University is a private research university in New Haven, Connecticut. It provides undergraduate, graduate, and professional education alongside research, scholarship, and public engagement.

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