CRA Exciting projects and end clients- Sign on bonus available

Job responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory (GPP) and protocol compliance.
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Demonstrates diligence in protecting the confidentiality of each subject/patient.
• Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

What we're looking for
* Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
* Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
* Must demonstrate good computer skills and be able to embrace new technologies
* Excellent communication, presentation and interpersonal skills
* Ability to manage required travel of up to 75% on a regular basis

• Must speak Dutch
• Must be EU national
• Must have 12 months independent monitoring experience

If you are having difficulty in applying or if you have any questions, please contact Jon Stewart at

020 3752 0318

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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