Clinical Research Associate

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Job description

Are you looking for an organization that encourages ideas, out of the box thinking and offers a safe place to grow?

On behalf of our client, we're searching for a talented and proactive Clinical Research Associate.

*Your New Role*

Are you a great communicator and strong negotiator with a passion for coordinating and monitoring (inter)national and multicentre clinical trials to assure clinical data quality? This could be the perfect match.

As Clinical Research Associate, you'll join an enthusiastic CRA team, currently existing of 15 CRA's, and report directly to the Manager Clinical Monitoring.

*Responsibilities*

* Monitors clinical research in accordance with the protocol, SOPs, applicable laws and ICH-GCP guidelines, including visit report compilation and follow-up within the set timelines.
* Performs feasibility, site selection, initiation, monitoring and closeout visits in accordance with contracted scope of work, using good clinical practices, applicable laws and regulations SOPs and Work Instruction.
* Performs feasibility, Medical ethics Committee Health authority activity and can be involved in contract negotiation activities with investigator or hospital.
* Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
* Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution;
* Train investigators and site staff (including laboratory, pharmacy and other staff involved) in the correct implementation of the protocol, the CRF and study-specific procedures and establish regular lines of communication with sites to manage ongoing project expectations and issues. And assists to organize CRA/ Investigator meetings, if applicable.
* Create and maintain appropriate documentation regarding site management, monitoring visit findings and action items by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.
* Ensures the correct reporting and follow-up of Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions;
*Do you enjoy?*

* Frequent travel?
* Developing and maintaining effective working relationships with site staff?
* Supporting the investigators during inspections by healthcare authorities or audits?
* SOP development, maintenance and training?
*Your Experience *

* Higher level of education, preferably in an (bio)medical field.
* At least one year of relevant experience, as a CRA, in clinical research.
* Up- to-date knowledge ICH-GCP guidelines, clinical trial regulations and legislation
* Strong oral and written communication skills in English and Dutch.
* Proactive, strong communication and negotiations skills.
* Ability to work independently as well as in a team matrix organization.
* Ability to travel on an irregular basis.
* Practical knowledge of Microsoft Office.
* Driver's License.

*More About Our Client*

A newly appointed CEO brings a fresh vision and an abundance of new approaches for this growing, well-connected CRO.

Are you looking to make an impact on medicine and patient lives? Join this progressive and innovative organization rooted in science, providing end-to-end CRO services in specific therapeutic areas and sought-after SMO services.

Employees have the flexibility to work from home, the office or a combination of the two.

*Application process*

We go beyond traditional recruitment; we work closely with you to ensure an unrivaled, personal candidate interview experience throughout our entire process.

Our long-standing relationship with this particular client allows us to fully support you through the recruitment process, providing you with all the role insight and knowledge you need for this 2 part interview process.

Our recruitment process is entirely confidential. Your details will never be shared without your prior consent.