Senior Clinical Research Associate

ARTO; Deutschland; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

ARTO is seeking an experienced Senior CRA to manage site selection and regulatory submissions for an international randomized clinical trial across Europe and the United States. The role involves onboarding support, informed consent prep, and coordination of regulatory submissions, including ethics committees and competent authorities.

Strong autonomy and familiarity with country-specific regulatory requirements are essential.

Qualifikationen

• Senior CRA with proven autonomy and accountability.
• Experience in site selection and regulatory submissions.
• Knowledge of local regulatory requirements across Europe and the US.
• Late-stage study experience (Phase II/III).
• Solid understanding of country-specific regulatory frameworks.

Aufgaben

• Lead site selection including on-site visits when required.
• Support site onboarding and informed consent preparation.
• Prepare regulatory submission packages for Ethics Committees and Competent Authorities.
• Coordinate adaptation of documents to local requirements and translations.
• Provide country-specific regulatory guidance across involved regions.

Kenntnisse

Site selection

Regulatory submissions

Autonomy

Late-stage studies

Regulatory frameworks

Local language readiness

Jobbeschreibung

The client is preparing the launch of an international randomized clinical trial (RCT) across Europe and the United States to support marketing authorization. Due to the absence of a full CRO model, key activities will be managed internally. We are therefore seeking experienced Senior CRAs to support site selection and regulatory submissions.

Scope of the mission

• Site selection (including on-site visits if required)
• Support to site onboarding and informed consent preparation
• Package preparation for Regulatory submissions (Ethics Committees / Competent Authorities)
• Adaptation of documents to local requirements and translation coordination
• Country-specific regulatory guidance

Profile requirements

• Senior CRA with strong autonomy
• Experience in site selection and submissions
• Knowledge of local regulatory requirements
• Late-stage study experience (phase II, III)
• Solid understanding of country-specific regulatory frameworks
• Local language may be required depending on country