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Yale University

Research university in New Haven, CT

Clinical Research Coordinator

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeNew Haven, CT, USA$65k - $101kHybrid

About the Job

Requirements

  • A bachelor's degree in a relevant academic or scientific field and at least three years of related research support experience, or an equivalent combination of education or experience.
  • Ability to lead a research team in executing trials within established study protocols and adapt to neurosurgery research involving adult and pediatric populations.
  • Ability to attend carefully to study requirements and regulatory constraints, follow through accurately, and prepare and submit regulatory documents and trial maintenance requirements.
  • Skill in obtaining informed consent, interacting with research subjects, tracking multiple occurrences and outcomes, and documenting them in a timely manner.
  • Ability to oversee and conduct human clinical research communications using multiple electronic data capture systems.
  • Knowledge of working with minimal supervision in a team setting and receptiveness to direction across disease areas.
  • Working knowledge of electronic data capture systems and ability to adopt new data management systems; strong regulatory skills.
  • Ability to collect specimens, process laboratory samples, take vital signs, and potentially stand for periods in the operating room.
  • Basic Life Support and Automated External Defibrillator certification; Clinical Coordinator Certification from SoCRA or equivalent.

Responsibilities

  • Support the Neurosurgery Research team in executing trials within the scope of each established study protocol.
  • Follow human-subject regulations defined by Yale University and the federal government that apply to research studies and human protection.
  • Coordinate research activities, work with a team to develop action items, keep projects on schedule, report project deliverable status, and draft and submit project updates to the Yale team and study sponsors.
  • 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 among Grants and Contracts offices, investigators, and business managers to resolve congruency issues promptly.
  • Attend meetings and present issues identified during congruency review when necessary.
  • Provide investigators and their staff with resources and technical assistance.
  • Provide analytical and technical support for establishing and recording protocol/grant congruency as needed.
  • Monitor federal and state regulations for new guidance, updates, or policies; maintain knowledge of these requirements and determine actions and follow directives needed to ensure University compliance with congruency review and reporting requirements.
  • Develop, implement, and manage internal practices that ensure compliance with federal requirements.
  • Perform other duties as assigned.

Desired Qualifications

  • Experience demonstrating the ability to work with minimal supervision in a team setting and receptiveness to direction regardless of disease area.
  • Working knowledge of electronic data capture systems, ability to adopt new data management systems, and strong regulatory skills.
  • Ability to collect specimens, process samples in a laboratory, execute vital-sign measurements, and potentially stand in the operating room.
  • Basic Life Support and Automated External Defibrillator certification; Clinical Coordinator Certification from SoCRA or equivalent.

About the Company

Yale University

Research university in New Haven, CT

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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