U

University of Pennsylvania

Ivy League university in Philadelphia, PA

Clinical Research Coordinator

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timePhiladelphia, PA, USA$46.5k - $48.5k /yr

About the Job

Requirements

  • A Bachelor of Science degree and 1 to 2 years of experience, or an equivalent combination of education and experience, is required.
  • Knowledge of Institutional Review Board and human research protection regulations is required.
  • Effective problem-solving abilities, communication and writing skills, organizational and time-management skills, flexibility, multitasking ability, and the ability to work both collaboratively and independently are required.

Responsibilities

  • Screen, recruit, and enroll consenting patients using Good Clinical Practice guidelines, and conduct compliance monitoring of study participants.
  • Conduct study-related visits, including blood draws, vital signs, medical history collection, electrocardiograms, biological specimen processing and shipping, and study data and regulatory-file management in accordance with Good Clinical Practice. Perform subject recruitment, informed consent, chart maintenance, and data entry.
  • Work with the Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audits and other quality-assurance activities, and handle monitor and audit visits with contract research organizations, the Food and Drug Administration, and other entities.
  • Order and stock supplies and maintain equipment.
  • Assist with preparation of research protocols and documents under supervision.
  • With the project manager’s help, manage, coordinate, and organize research assistants’ daily work on recruitment, study visits, and regulatory tasks, and train them in these tasks.
  • Attend Investigator Meetings and communicate meeting information to the study team.
  • Perform additional duties as assigned.

Desired Qualifications

  • Prior experience in gene therapy trials is preferred.

About the Company

University of Pennsylvania

Ivy League university in Philadelphia, PA

The University of Pennsylvania is a private Ivy League research university in Philadelphia. It comprises twelve undergraduate, graduate, and professional schools, including the Wharton School, Perelman School of Medicine, and Penn Carey Law.

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