Clinical Research Associate senior

Senior Clinical Research Associate - Noord Holland (12 Months)

Clinical Research Associate

CRA Project management, Senior Clinical Research, Clinical Research Associate, Pharmaceutical, Biotech, freelance, Netherlands, Clinical research, Senior CRA

My client is a leading Life Sciences company specialising in the area of Oncology, committed to improving access to healthcare and supporting the people they serve throughout the continuum of care. They are currently expanding their clinical operations team to welcome a number of senior Clinical Research Associates (SCRA) to work on several studies at their offices in Noord Holland.

The successful Senior Clinical Research Associate(s) will be accountable for the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.

The successful Clinical Research Associates will have

* Degree level education in Health Sciences or a relevant discipline and/or considerable knowledge working as a Clinical Research Associate
* Previous clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) for research sites in compliance with the approved protocol
* Experience in clinical study protocol development and ethical submissions
* Excellent communication skills for ongoing communication with the medical site staff (coordinators, clinical researchers and their site staff)
* Advanced proficiency in English, both verbal and written. Speaking Dutch is an advantage.

The Role

* Monitor clinical trials to ensure absolute adherence to good clinical practice in accordance with ICH-GCP standards.
* Site management to ensure adequate adherence to protocol, source data verification and assess CRF entries
* Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists
* Liaise with the Medical Monitor, Principle Investigator, Clinical Operations staff and sponsor representatives as required
* Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.
* Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements

Our client is a well known and respected global pharmaceutical organisation, based in North Holland. They offer the successful Senior Clinical Research Associates the opportunity to work on a large and challenging new project with an immediate start.

Get in touch

If you think you meet the criteria for this role, please apply to this post or forward your CV to me directly at Rohaan.khan.

Amoria Bond operates as an employment agency and employment business. No terminology in this advert is intended to discriminate on the grounds of age or experience, and we confirm that we are happy to accept applications from persons of any age or experience for this role.