Clinical Research Coordinator A (Department of Obstetrics & Gynecology)

University of PennsylvaniaWoodworth, OH
Onsite

About The Position

The primary role of the Clinical Research Coordinator is the organization and implementation of a research study. The research coordinator will be responsible for all aspects of clinical trial coordination including: subject recruitment, detailed data entry, subject visits and medical chart follow-up, biospecimen collection across multiple locations across the health system, biospecimen processing, and regulatory management. This position involves working directly with several Investigators to develop a biobank of blood specimen from participants in early pregnancy. The position involves abstracting information from medical records of pregnancy outcomes. You will coordinate with investigators and coordinators at other universities to collect specimen and data for this project.

Requirements

  • Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.
  • Highly motivated individual who can both collaborate as a team member and work independently on data collection and abstraction.
  • Interested in learning about early pregnancy and reproductive endocrinology.

Nice To Haves

  • Experience with electronic medical records and REDCap is a plus.

Responsibilities

  • Assist in the implementation of study protocol.
  • Perform required research activities per protocol and in accordance with Good Clinical Practice
  • Coordinate and conduct clinical studies, includes; subject recruitment, informed consent, chart maintenance and data entry
  • Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines
  • Assure compliance with the protocol and regulatory requirements includes: collecting, recording, and maintaining data and source documentations.
  • Collect and process biospecimens (included performing venipuncture).
  • Assist with biospecimen tracking and management.
  • Interface with the study investigator.
  • Attend weekly meeting with the study team and study investigator.
  • Organize and participate in site visits, both initiation and otherwise.
  • Prepare and host both internal and external auditing and monitoring activities.
  • Promote good clinical practice in the conduct of clinical investigations, included possessing an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protection
  • Other duties and responsibilities as assigned

Benefits

  • Excellent healthcare
  • Tuition benefits for employees and their families
  • Generous retirement benefits
  • A wide variety of professional development opportunities
  • Supportive work and family benefits
  • A wealth of health and wellness programs and resources
  • Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
  • Flexible spending accounts
  • Tuition assistance for employee, spouse, and dependent children
  • Generous retirement plans
  • Substantial amount of time away from work
  • Long-Term Care Insurance
  • Wellness and Work-life Resources
  • Professional and Personal Development resources
  • Access to a wide range of University resources as well as cultural and recreational activities
  • Discounts and Special Services
  • Flexible Work Hours
  • Penn Home Ownership Services
  • Adoption Assistance
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