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Contract CRA

Company Name:
BioBridges, LLC
Contract CRA
Overview
Our client is a biopharmaceutical company at the forefront of therapies for rare and orphan diseases.
Their Clinical Divide
The Clinical Research Associate is responsible for assisting the Clinical Operations team(s) in overseeing sites conduct of clinical studies through monitoring and efficiently and effectively communicating site related items to the study team.
Project Details
Responsibilities include:
Oversee the progress of the clinical trial and ensure that the trial is conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOPs), GCP and applicable regulatory requirements.
The monitor should verify: that the rights and well being of human subjects are protected, that the reported trial data are accurate, complete and verifiable from source documents and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP and with applicable regulatory requirement(s).
Activities to be carried out by the monitor include (not limited to the below):
Be primary point of contact for sites
Build and maintain relationship with sites
Monitor sites (Initiation Visits, Routine Visits, Close Out Visits, etc.)
Produce monitoring reports within (draft and final) outlined SOP timelines
Coach investigators to be compliant with GCPs and the protocol
Talk to site staff about site recruitment
Ensure sufficient drug supply on site and reconcile drug on site
Ensure high quality data and conduct at sites
Identify and escalate issues or concerns to the internal team
Identify, analyze problems and trends; provide and recommend solutions across studies
Acts as primary liaison between CRO CRAs, Field Based CRAs and the PM
Ensure that monitoring visits are performed in accordance with protocol/SOP requirements and that these are tracked, including report status and sign off.
Requirements:
Minimum of Bachelors Degree, Nursing Degree preferred.
o 4+ years experience from similar work within a pharmaceutical company or CRO is preferable, but can also have experience as a research coordinator (desired)
o Travel 80-90%
Scope
Contract duration 9 months. Will be required to work onsite in their office when not traveling.

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