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Doc Review I

Covance 3/29/2019 1:12:22 PM
JOB ID: 29057 Category: Contracts Administration
Buenos Aires, Argentina

   

 

Job Overview

* Review Initial/Amended Investigator Packages to assure compliance with regulatory requirements before granting regulatory green light to a site to start enrolling patients into the clinical trial
* Review Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines
* Review Patient Recruiting materials (Advertisements) to assure compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines
* File Informed Consent Form , Patient Recruiting materials, and Investigator Package approval documentation in TMF and eTMF
* Review Investigator Package Plans that document the required quality of documents included in Investigator Packages following the available SOP with manager oversight
* Review protocol amendment to reconfirm completeness and to assure compliance with Good Clinical Practice (GCP) guidelines
* Review revised Core Informed Consent Forms to reconfirm compliance with sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines
* Provide input for Corrective and Preventative Actions (CAPAs) related to Document Review activities including Informed Consent Form Review, Patient Recruiting material Review and Investigator Package Review

Education/Qualifications

University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology)

Experience

Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines;

2 years work Experience in clinical research previous interaction with operational project teams preferred


Position Type: Full-Time

Location: Buenos Aires, ARG - Argentina



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Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit www.gettinghired.com or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).