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Unblinded Monitor- CRA (Freelancer)

  • TFS
  • Full time
  • Germany
  • 02/04/2021

TFS is recruiting a CRA to be part of our growing organization and to be fully outsourced to a prestigious sponsor.

In this role you will:

- Liaison with key unblinded trial personnel at clinical trial centres in an effective and professional manner ensuring that site staff members can work in a coordinated manner without compromising the blinded study concept.

- Training clinical site staff in drug dispensing procedures and unmasked processes.

- Monitoring investigational medicinal products (IMP) at site to ensure that all products are delivered, maintained in suitable storage conditions, dispensed/ administered, accounted for, returned and/or destroyed in the correct manner and assuring that IMP data is valid. Follows up on outstanding actions with study sites to ensure resolution in a timely manner

- Managing/Monitoring the sites for any clinical trial (IMP) related issues and escalating as necessary.

- Perform monitoring visits in accordance with the timelines specified in the Unblinding study specific Monitoring Plan. Short contacts with the sites, site training, monitoring plan adherence, ect, but also study team management. Stock management at sites.

- Completing documentation such as monitoring visit reports, IMP logs, training logs and trackers in a timely manner. Unblinded ISF and TMF management

- Preparation and participation in the setup, maintenance and close out of clinical trial centres, ensuring patients safety of and confirming that clinical centres adhere to the standards of ICH Good Clinical Practice and Sponsor standard operating procedures (SOPs).

- Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local CQM as required



Requirements

To be successful in this role you have previous monitoring experience

Experience handling IMP

Understanding of the unblinded studies expectations

You are fluent in English and German

You have a positive mindset and a flexible attitude

Ability to travel nationally



Benefits

Competitive rate and long assignment

Work with major sponsor


About TFS

We believe that a company with ethical and transparent values has a better chance of attracting skilled employees and building long-term relationships.

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