Clinical Research Associate

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Are you ready to contribute your expertise to the advancement of healthcare and join a dynamic team dedicated to patient well-being?

This role provides you with a meaningful journey in medical technology.

My client is a renowned leader in medical technology, dedicated to enhancing patients' lives for over four decades. Through inventive products, a collaborative culture, and an unwavering commitment to human well-being, they tackle the most pressing challenges in healthcare.

About my client

My client is seeking a driven and motivated individual to join their team in Germany within the Global Clinical Operations Center of Excellence. This role offers a unique blend of remote work and field assignments, allowing you to make an immediate impact.

You'll play a pivotal role in collaborating closely with various divisions, you'll contribute to clinical technologies, process innovations, and study acceleration. My client provides technological support, customer service, and the tools needed for top-tier data collection.

Responsibilities

• Source Review: Match case report form data to source documents, review informed consent forms (ICFs), regulatory documents, and product stewardship records.
• Communication: Maintain clear communication with clinical facilities and project team members through surveillance reports, follow-up letters, and study memos.
• Training: Ensure proper training of all personnel for conducting clinical studies in alignment with protocols and regulations.
• Compliance: Uphold compliance with legal regulations (ICH/GCP, MDR, GDPR, etc.), internal standard operating procedures, and policies.
• Escalation Processes: Address site non-compliance issues through effective communication, documentation, and resolution, supporting internal quality audits and regulatory inspections.
• Event Reporting: Identify, document, and report reportable events as per protocols and requirements.
• Collaboration: Participate in study-specific meetings, conference calls, and training sessions, collaborating with cross-functional team members and study sites across all study phases.
• Documentation: Administer study contracts, acquire investigator/site documentation, and manage documents in the relevant databases.
• Site Commissioning: Coordinate activities for regulatory submissions, and essential document collection, and collaborate with clinical centers for ICF negotiation and adaptation.
• Timeline Monitoring: Assist clinical research centers in submission processes, ensuring ethics committee timeline adherence, and tracking approvals.
• Trial Maintenance: Update and maintain trial-specific startup trackers, site-specific metrics in Clinical Trial Management systems, and site startup documents in eTMFs (electronic Trial Master Files).

Your Profile

• Successfully completed business administration (technical) university degree or equivalent commercial training with relevant professional experience.
• Several years of experience in clinical research and field monitoring.
• Excellent communication and presentation skills, along with the ability to engage effectively with clinical research institutions.
• Team player with strong interpersonal skills, empathy, and an ability to communicate at all levels.
• Fluent proficiency in German and English, both written and spoken.
• Willingness to travel (approximately 25%) with residency in Germany, and occasional trips to Austria and Switzerland.

Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).

Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.

We do not ask for a placement fee from Candidates/Employees.

If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09

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