Clinical Research Coordinator A (Department of Obstetrics & Gynecology)

Job Profile Title

Clinical Research Coordinator A

Job Description Summary

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 manage and run several different studies. The tasks involved in these studies include recruitment of study participants including finding eligible participants through medical records or scheduled patient visits, conducting informed consent discussions, collecting and processing placentas from study participants, assisting with participant visits: including blood draws and exams, as well as submitting modifications and continuing reviews to the IRB. The position involves abstracting information from medical records and data entry. This study will involve a collaboration with other medical and fertility centers and investigators at CHOP.

Job Description

Job Responsibilities

• Assist in planning and implementation of patient recruitment into studies and screen, recruit and retain potential study participants.
• Collect and process biospecimens (included performing venipuncture). Assist with biospecimen tracking and management.
• 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
• Interface with the study investigator. Attend weekly meetings 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.
• Assure compliance with the protocol and regulatory requirements includes: collecting, recording, and maintaining data and source documentations.
• 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

*Position contingent upon continued funding.*

Qualifications

This position is looking to hire a highly motivated individual who can both collaborate as a team member and work independently on data collection and abstraction. The coordinator should be interested in learning about fertility and reproductive endocrinology.

• Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.
• Experience with electronic medical records and REDCap is a plus.