Clinical Research Associate

Veeda Lifesciences; Düsseldorf; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A global CRO is seeking a Clinical Research Associate (CRA) based in Germany to manage clinical trial compliance and monitor operations in the DACH region. The ideal candidate should have a degree in Health Sciences, 6-12 months experience as a CRA, and be fluent in English and German. This full-time position offers a competitive remuneration package and necessitates frequent travel. Join a multidisciplinary team in a friendly environment.

Leistungen

Competitive remuneration package

Qualifikationen

• 6-12 months’ experience as a CRA is required.
• ICH GCP training is desirable.
• Ability to work independently and collaboratively is necessary.

Aufgaben

• Ensure compliance with Quality Management Systems and regulations.
• Conduct pre-study visits to evaluate investigational sites.
• Monitor clinical trial conduct at sites and verify investigator qualifications.

Kenntnisse

Fluent in English

Fluent in German

Strong communication skills

Organizational skills

Ability to handle stressful situations

Ausbildung

Bachelor’s or Master’s degree in Health Sciences or related field

Tools

Proficient computer skills

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.

He/she serves as the primary communication link for operational study activities between the Sponsor, Investigators, and study personnel to foster successful collaborations.

The key responsibility is to ensure respect for subjects’ rights and the accuracy, completeness, and verifiability of all collected clinical trial data from source documents.

Main responsibilities :

• Ensure compliance with the Company’s Quality and Information Security Management Systems, ICH GCP, local and international legislation, including data protection laws, and update as necessary.
• Report deviations from protocols, GCP guidelines, or legislation to the Line Manager according to SOPs.
• Conduct pre-study visits to evaluate potential investigational sites’ resources and facilities.
• Collaborate with Regulatory Affairs and Clinical Operations for submissions and contracts, including hospital IEC study submissions and approvals, and study financial documentation.
• Explain study purposes, setup, and procedures to Investigators and provide training and support.
• Maintain and update Clinical Trial Files, ensuring proper documentation collection.
• Supply sites with study medication, verify drug accountability, and oversee shipment, storage, dispensing, and disposal.
• Monitor clinical trial conduct at sites, including verifying investigator qualifications, reviewing source data, and ensuring informed consent is obtained and documented properly.
• Coordinate safety reporting to the Sponsor and ensure investigators are trained in AE/SAE reporting.
• Ensure timely submissions to IEC/IRB and regulatory authorities.
• Perform drug accountability and proper dispensing.
• Document monitoring activities and communicate findings to investigators and management.
• Participate in meetings and provide feedback on trial progress.
• Assist in audits and regulatory inspections, facilitating site preparation and corrective actions.
• Support site feasibility, patient recruitment, and study closure activities.
• Contribute to departmental planning and SOP development.
• Provide coaching and mentorship to less experienced CRAs.
• Monitor the DACH region.

Job Requirements :

• Bachelor’s or Master’s degree in Health Sciences or related field.
• 6-12 months’ experience as a CRA.
• Fluent in English and German (oral and written).
• ICH GCP training (desirable).
• Proficient computer skills.
• Strong communication and organizational skills.
• Ability to work independently and collaboratively.
• Effective communication with study site personnel.
• Ability to handle stressful situations, meet deadlines, and manage multiple issues.
• Adherence to SOPs, guidelines, regulations, and ethical principles.
• Willingness to travel frequently, including evenings and overnight stays.

Join our multidisciplinary team of scientists and healthcare professionals at the forefront of clinical research in a friendly environment.

Competitive remuneration package included.

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