Clinical Research Coordinator


Medical and Nursing

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Salary Range

Based on Experience

No. of Openings


Branch Information

Frederick, MD - Professional - (USA) 7470 New Technology Way (Professional) MD Frederick , MD 21703



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!