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
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
Competitive rate and long assignment
Work with major sponsor