Clinical Research Coordinator A (Department of Obstetrics & Gynecology)

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 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.

Job Description

Job 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

*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 early pregnancy 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.