Full-Time

Clinical Research Coordinator

Perelman School of Medicine

University of Pennsylvania

University of Pennsylvania

Ivy League university in Philadelphia, PA

Compensation Overview

$47.3k - $48k/yr

Philadelphia, PA, USA

In Person

Bachelor of Science (BS)

Category
Biology & Biotech (1)
Required Skills
Patient Care

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Requirements
  • A Bachelor of Science and 1 to 2 years of experience, or an equivalent combination of education and experience, is required.
Responsibilities
  • Review and comprehend assigned protocols, including study procedures and timelines, to ensure that clinical research and related activities are performed in accordance with the protocol, standard operating procedures, Good Clinical Practice, and applicable regulatory requirements.
  • Facilitate approval of new study agreements and contracts.
  • Assist with developing study materials, including informed consent documents, case report forms, and study logs.
  • Recruit and enroll study participants, coordinate study visits, and serve as liaison between participants, the principal investigator, study team members, and external sponsor or contract research organization teams.
  • Collect clinical data, complete source documents, and collect, process, and ship biological samples.
  • Complete electronic case report forms according to source documents and respond to data clarification requests in a timely manner.
  • Establish and maintain study files, including regulatory binders, study-specific source documentation, and other required materials.
  • Prepare and manage regulatory submissions and inquiries.
  • Coordinate and attend investigator meetings, site selection visits, routine monitoring visits, and study closeout visits.
  • Work with the study principal investigator and study team to identify problems, develop solutions, implement approved procedural changes, and monitor results.
  • Train junior members of the research team when applicable.
  • Communicate with patients and staff outside office hours, including evenings or weekends as necessary.
  • Demonstrate competence in the assessment, treatment, and care of patients while providing courteous, respectful, professional, and compassionate service.
Desired Qualifications
  • Strong planning, organizational, multitasking, and prioritization capabilities.
  • Ability to work independently and as part of a team.
  • Ability to communicate effectively with clinicians, researchers, sponsors, patients, and families.
  • Prior experience with industry-sponsored trials, startup activities involving financial and regulatory matters, ethics committees, and human subject research policies and practices.
University of Pennsylvania

University of Pennsylvania

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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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