skip to main content

Important Notice

It appears you are using an older version of your browser. While some functions will be available, IllinoisJobLink.com works best with a modern browser such as the ones provided by:

Please download and install the latest version of the browser of your choice. We apologize for any inconvenience.



CTA III

Click the Facebook, Google+ or LinkedIn icons to share this job with your friends or contacts. Click the Twitter icon to tweet this job to your followers. Click the link button to view the URL of the job, which then can be copied and pasted into an e-mail or other document.

Job Details
Job Order Number
JC180674640
Company Name
DOCS
Physical Address

Springfield, IL 62762
Job Description

CTA III

Ref #: 28107

Employment type: Permanent – Full-Time

Location: United States

Posted: 15-Mar-2021

Description

Major Accountabilities

1. Drive site activation activities for the US in collaboration with the CSM, Field Team and the Global team.

2. Develop for the US a detailed study start-up and site activation plan, including timelines, potential risks with planned mitigations. Drive proactive risk mitigation and effective startup scenario generation and planning through data driven analysis utilizing internal and external data sources

3. Drive local Full Protocol Package process by obtaining all required documentation for the country for Health Authority (HA) and/or Institutional Review Board (IRB)/Institutional Ethics Committee (IEC) submissions; Obtain global documents required for site activation from the Global Study Start-Up Lead or Equivalent

4. Ensures CREDI-approved ICF is used as the source for the US-Customized ICF template for the study. Reviews and negotiates the legal sections of the ICF pre-IRB submission, post IRB approval, and for all amended ICFs.

5. Drive EC/IRB submission/approval process, coordinates timely answers to EC/IRB questions.

6. Single point of contact for CTA Hub/HA submission process, ensure availability of relevant HA submission status and information.

7. Project drug supply needs/challenges for all US studies to prevent drug supply delays and interruptions. Oversees the planning, creation, distribution and maintenance of clinical drug supplies for all US studies. Manages all drug supply management from tracking importation, inspection, delivery to depot and entry into inventory.

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer – Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

\#ctajob


To view full details and how to apply, please login or create a Job Seeker account.