Job Details
The Company
Our client is looking for a Clinical Research Coordinator for their rapidly expanding company that has recently secured additional investment to fuel their growth. Established in 2015, they have expanded to 11 sites, conducting over 400 clinical studies spanning Phase I to IV, primarily focusing on GI, Hepatology, and CNS.
This role will be onsite in Jackson, NJ!
Responsibilities:-
As a Clinical Research Coordinator, you will be a specialized research professional under the direction of the clinical Principal Investigator and Site Manager. While the PI and Site Manager are responsible for the overall design, conduct, and management of the clinical trial, you support, facilitate, and coordinate the daily clinical trial activities and play a critical role in the conduct of the study including supporting patients throughout the clinical trial process!
- Conducts assigned studies according to protocol & procedures, and in compliance with FDA, GCP, and ICH regulations and guidelines.
- Scheduling and Screening of patients for study enrollment, consents, follow-ups
- Documenting charts entering data in EDC and answering queries
- Obtaining vital signs, ECGs, and lab procedures such as blood draw or scans
- Maintaining & ordering study specific supplies;
- Conducting monitoring visits, Prepare and attend site initiation visits (SIV s) and Investigator Meetings (IMs)
- Filing SAE/Deviation reports to Sponsor and IRB; Handles all IRB functions
- Documenting and reporting adverse events
- Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF
Qualifications:-
- 2+ years of Clinical Research experience working with industry sponsored trials as a Clinical Research Coordinator.
- Proficiency in vitals, phlebotomy, and ECG.
- Previous GI experience highly preferred.