Clinical Research Associate

Advanced Resource Managers; Deutschland; Vor Ort; EUR 42.000 - 62.000; Vollzeit

Zusammenfassung

Advanced Resource Managers is seeking experienced CRAs to join a large International CRO team in Germany. The role targets professionals with at least 1 year of independent monitoring experience and fluent German.

Expect 5–7 site visits per month nationwide as part of ongoing studies across multiple therapeutic areas. Responsibilities include initiation, monitoring, and close-out visits, data verification, and collaboration with investigative sites to ensure protocol compliance and patient

Qualifikationen

• 1 year independent monitoring experience, preferably in a CRO setting.
• Fluent in German (minimum C1 level).

Aufgaben

• Conduct site initiation, monitoring, and close-out visits in accordance with study protocols, regulatory requirements, and SOPs.
• Perform site qualification, initiation, routine monitoring, and site closure activities with a focus on data integrity, patient safety, and protocol compliance.
• Develop and maintain strong relationships with investigative sites, ensuring effective communication and collaboration throughout the study.
• Review and verify clinical data, source documents, and study records to ensure accuracy, completeness, and regulatory compliance.
• Proactively identify and resolve study-related issues and discrepancies, escalating as necessary to meet timelines.
• Assist in development and review of study-related documents including protocols, informed consent forms, case report forms, and study manuals.
• Provide support and guidance to junior team members, including training, mentoring, and oversight as needed.

Kenntnisse

German language (C1)

Jobbeschreibung

My client, a large International CRO are looking for experienced CRA's to join their team in Germany. This is working on behalf of an industry leading company, with projects available across a variety of therapeutic areas.

If you are an experienced CRA with a minimum of 1 years experience and are looking for a company where you can expediate your development, my client offers the perfect working environment to do just that due to the strong management team in place in Germany.

Please see expectations below:

• 1 years independent monitoring experience, preferably in a CRO setting
• Fluent in German (minimum C1 level)
• Ability to perform 5-7 visits per month nationwide

Responsibilities include:

• Conduct site initiation, monitoring, and close-out visits in accordance with study protocols, regulatory requirements, and standard operating procedures (SOPs).
• Perform site qualification, initiation, routine monitoring, and site closure activities with a focus on data integrity, patient safety, and protocol compliance.
• Develop and maintain strong relationships with investigative sites, ensuring effective communication and collaboration throughout the duration of the study.
• Review and verify clinical data, source documents, and study records to ensure accuracy, completeness, and compliance with applicable regulations.
• Proactively identify and resolve study-related issues and discrepancies, escalating as necessary to ensure timely resolution and adherence to project timelines.
• Assist in the development and review of study-related documents, including protocols, informed consent forms, case report forms, and study manuals.
• Provide support and guidance to junior team members, including training, mentoring, and oversight as needed.