Clinical Research Associate

Veeda Lifesciences; Essen; Vor Ort; EUR 45.000 - 60.000; Vollzeit

Zusammenfassung

A global CRO is seeking a Clinical Research Associate (CRA) in Germany to manage and ensure compliance during clinical trials within the hematology/oncology sector. The role requires fluent English and German, alongside 6-12 months of relevant CRA experience. Offering a dynamic work environment with a competitive remuneration package.

Leistungen

Competitive remuneration package

Qualifikationen

• 6-12 months’ CRA experience.
• ICH GCP training is desirable.
• Ability to work independently and as part of a team.

Aufgaben

• Ensure compliance with protocols and guidelines.
• Conduct pre-study visits and monitor clinical trials.
• Manage subject recruitment and timelines.

Kenntnisse

Fluent in English

Fluent in German

Strong communication skills

Organizational skills

Proficient computer skills

Ausbildung

Bachelor's or master's degree in Health Sciences

Jobbeschreibung

Heads, a global CRO and part of Veeda Lifesciences, is seeking a Clinical Research Associate (CRA) based in Germany for its expanding international hematology/oncology clinical trials program.

This is a full-time position.

Job overview:

The CRA is responsible for ensuring that the conduct of clinical trials at selected investigational sites complies with the approved protocol/amendments, ICH GCP guidelines, SOPs, and applicable laws and regulations.

The CRA acts as the primary communication link between the Sponsor, Investigators, and study personnel to foster successful working relationships.

The key responsibility is to safeguard subjects' rights and ensure that all clinical data collected are accurate, complete, and verifiable from source documents.

Main responsibilities:

• Ensure compliance with the company’s Quality and Information Security Management Systems, ICH GCP guidelines, and applicable legislation, including data protection laws.
• Report deviations from protocol, GCP guidelines, or legislation to the Line Manager according to SOPs.
• Conduct pre-study visits to evaluate potential investigational sites.
• Collaborate with Regulatory Affairs and Clinical Operations for submissions and contracts, including hospital IEC submissions and approvals.
• Prepare study contracts and relevant documentation for financial management.
• Explain study purposes and procedures to Investigators; provide training and support.
• Maintain and update clinical trial files, ensuring proper documentation.
• Supply sites with study medication, verify drug accountability, and oversee storage and handling.
• Monitor clinical trial conduct, including site visits, to ensure protocol adherence and data integrity.
• Verify informed consent procedures and ensure compliance with GCP and legislation.
• Manage subject recruitment, timelines, and site supplies.
• Report safety information and ensure investigators are trained in AE/SAE reporting.
• Ensure timely submissions to IEC/IRB and regulatory authorities.
• Perform drug accountability and proper dispensation.
• Document monitoring activities and communicate findings to investigators.
• Participate in meetings and reviews, and prepare for audits or inspections.
• Support site feasibility, patient recruitment, and study closure activities.
• Mentor and coach new or less experienced CRAs.
• Monitor the DACH region.

Job requirements:

• Bachelor’s or master’s degree in Health Sciences preferred.
• 6-12 months’ CRA experience.
• Fluent in English and German, both oral and written.
• ICH GCP training (desirable).
• Proficient computer skills.
• Strong communication and organizational skills.
• Ability to work independently and as part of a team.
• Effective communication with site personnel.
• Ability to handle stress, manage timelines, and multitask.
• Adherence to SOPs, guidelines, and ethical principles.
• Willingness to travel frequently, including evenings and overnight stays.

Join our multidisciplinary team of scientists and healthcare professionals in a dynamic and friendly environment. We offer a competitive remuneration package.

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