Clinical Research Associate

Oxford Global Resources; Berlin; Remote; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading clinical research organization is seeking an experienced Clinical Research Associate (CRA) to support monitoring and site management across multiple studies. In this remote role, you will conduct monitoring activities, support site start-up, and ensure compliance with regulations. Ideal candidates should have prior CRA experience, excellent organizational and communication skills, and a proactive attitude towards patient safety. This position offers a dynamic working environment with exposure to multiple studies.

Qualifikationen

• Experience within medical devices or pharma.
• Strong knowledge of regulatory requirements.
• Commitment to patient safety and quality standards.

Aufgaben

• Conduct on-site and remote monitoring activities.
• Support site start-up activities including submissions.
• Attend study meetings and collaborate with teams.
• Provide support in audit preparation and responses.
• Ensure monitoring reports are finalized on time.

Kenntnisse

Prior CRA experience (on-site and remote)

Knowledge of EC/CA submission processes

Excellent organizational skills

Strong communication skills

Detail-oriented

Jobbeschreibung

Clinical Research Associate (CRA)

Location: Flexible (remote role)

Description of Services

We are seeking an experienced Clinical Research Associate (CRA) to support monitoring and site management activities across multiple studies. The role involves close collaboration with study teams, sites, and cross-functional stakeholders, with a strong commitment to patient safety, data integrity, and product quality.

Key Responsibilities (include but are not limited to):

• Conduct on-site and remote monitoring activities, including visit preparation, follow-up, site contact, and report writing.
• Support site start-up activities, including EC/CA submissions, contract negotiation, and essential document collection.
• Attend study meetings and collaborate with cross-functional teams and sites throughout all study phases.
• Provide support in audit preparation and responses.
• Schedule and conduct monitoring visits according to the study monitoring plan.
• Review informed consents, regulatory files, and site study documentation, ensuring compliance with study protocols and applicable regulations (ISO 14155:2020, ICH-GCP).
• Identify and report compliance issues, working with project management to ensure timely resolution.
• Ensure monitoring reports are finalized within 28 days of each site visit.
• Provide interim site management services, including remote monitoring, as required.

Qualifications:

• Prior CRA experience (on-site and remote) within medical devices or pharma (ISO 14155:2020, ICH-GCP).
• Strong knowledge of EC/CA submission processes and regulatory requirements.
• Excellent organizational and communication skills, with ability to collaborate across cross-functional teams.
• Proactive, detail-oriented, and committed to patient safety and quality standards.

✨ This opportunity offers involvement in multiple excluively sponsor studies, exposure to a wide range of clinical operations, and the chance to work in a dynamic, high-quality environment.