Job Description
Clinical Research Coordinator
Are you passionate about clinical trials? Do you bring 2+ years of clinical research experience? In this position, you will:
* Provide clinical trials monitoring.
* Ensures sites are following U.S. Food and Drug Administration (FDA) regulations for INDs, Investigational Device Exemptions (IDEs), International Conference on Harmonisation (ICH)/ Good Clinical Practice (GCP) guidelines, and other applicable regulations
* Verifies source documentation for the appropriate recording and reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs).
* Critically evaluates clinical data for accuracy and completeness while ensuring the safety and confidentiality of participants according to the study monitoring plans.
* Provides monitoring of pharmacy records, including receipt, storage, labeling and final packaging, inventory, distribution, accountability and the processing and disposal of returned investigational agents.
* Coordinates monitoring activities of clinical studies for domestic and international sites including: conducting site initiation, monitoring and close-out visits, completing reports in a timely manner, ensuring the conduct of the trial is in compliance with the approved protocol, SOPs, ICH/GCPs, Institutional Review Board (IRB)s and applicable regulatory requirements
* Assists in the preparation and production of documents for FDA submissions, as well as IND annual protocol reports and manuscripts.
* Maintains Essential Documentation File contents and reconciliation of the documentation including ensuring all required essential study documents are current, complete and accurate.
* Ensures Clinical Trial Database Systems are updated to be current, accurate and complete in a timely manner.
Interested? Well qualified candidates will bring:
* A Bachelor's degree in a related field of study
* 2+ years of clinical trials experience
* Certified Clinical Research Professional (CCRP) preferred
* A current nursing license would be a plus
Apply today to learn more about this tremendous opportunity to be involved with COVID clinical trials!