Covance

Centralized Study Spec II

Job Location(s) CN-Dalian
Job Number
2021-72835
Job Category
Clinical Study Start Up
Position Type
Full-Time
Telecommute
No

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

Recommended:
University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate
accredited institution (Ex: Nursing certification, Medical or laboratory technology) and 02-03 years of work
experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other
applicable guidelines and regulations.

Experience

Recommended:
University/College Degree (Life Science preferred), or certification in an allied health profession from an appropriate
accredited institution (Ex: Nursing certification, Medical or laboratory technology) and 02-03 years of work
experience in clinical research, including a strong working knowledge of the ICH-GCP guidelines and all other
applicable guidelines and regulations.

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