Clinical Research Associate

Advanced Resource Managers; Deutschland; Vor Ort; EUR 42.000 - 58.000; Vollzeit

Zusammenfassung

Advanced Resource Managers is seeking an experienced CRA to join our client’s team in Germany. The role involves conducting site initiation, monitoring, and close-out visits across Germany, ensuring data integrity and regulatory compliance.

Ideal candidates have at least 1 year of independent monitoring experience, fluent German (C1), and can manage 5–7 site visits per month nationwide while supporting junior team members as needed.

Qualifikationen

• 1 year of independent monitoring experience in a CRO or similar setting.
• Fluent German with C1 level or higher.
• Ability to conduct 5–7 visits per month across Germany.

Aufgaben

• Conduct site initiation, monitoring, and close-out visits per study protocol and SOPs.
• Perform site qualification, initiation, routine monitoring, and site closure activities.
• Develop and maintain relationships with investigative sites and ensure effective communication.
• Review and verify clinical data, source documents, and study records for accuracy and compliance.
• Identify and resolve study-related issues, escalating to ensure timelines are met.
• Assist in development and review of study documents including CRFs and study manuals.
• Provide guidance to junior team members including training and oversight.

Kenntnisse

Independent monitoring

German language proficiency

Site visits planning

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.