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- Aufgaben: Join our team as a Senior Clinical Research Associate, managing site visits and ensuring compliance.
- Arbeitgeber: Syneos Health is a top biopharmaceutical solutions organization focused on accelerating success.
- Mitarbeitervorteile: Enjoy remote work flexibility and the chance to work with a diverse, inclusive team.
- Warum dieser Job: Make an impact in clinical research while developing your skills in a supportive environment.
- Gewünschte Qualifikationen: Bachelor’s degree or RN required; previous monitoring experience and fluency in German are essential.
- Andere Informationen: Be part of a company that values diversity and offers growth opportunities.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
Updated: Yesterday
Location: Germany-Europe – DEU-Home-Based
Job ID: 25001682
We are currently recruiting for an experienced Clinical Research Associate to join our multi-sponsor team here in Germany.
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Job Responsibilities
- Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
- Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
- Per the Clinical Monitoring/Site Management Plan (CMP/SMP):
- Assesses site processes
- Conducts Source Document Review of appropriate site source documents and medical records
- Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records
- May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
- Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
- Understands project scope, budgets, and timelines for own and others’ activities in the clinical team.
- May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate.
- Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- May provide training or mentorship to more junior level CRAs.
Qualifications
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Previous monitoring experience.
- Must demonstrate good computer skills and be able to embrace new technologies.
- Excellent communication, presentation and interpersonal skills.
- Fluency in German.
- Ability to manage required travel.
Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered. The Company will determine what constitutes as equivalent to the qualifications described above.
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace.
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senior CRA Germany Arbeitgeber: Syneos Health, Inc.
Kontaktperson:
Syneos Health, Inc. HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: senior CRA Germany
✨Tip Number 1
Make sure to highlight your previous monitoring experience during any conversations or interviews. This role requires a solid background in clinical research, so be ready to discuss specific projects you've worked on and the impact you made.
✨Tip Number 2
Familiarize yourself with Good Clinical Practice (GCP) and ICH Guidelines. Being able to speak knowledgeably about these regulations will demonstrate your expertise and commitment to compliance, which is crucial for this position.
✨Tip Number 3
Since this role involves site management and communication with project site personnel, practice your interpersonal and presentation skills. Being able to effectively communicate and build relationships will set you apart from other candidates.
✨Tip Number 4
As fluency in German is required, consider brushing up on your language skills if needed. Being able to communicate clearly in German will not only help you in the application process but also in your day-to-day responsibilities.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: senior CRA Germany
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Clinical Research Associate position. Understand the key responsibilities and qualifications required, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize your previous monitoring experience and any relevant qualifications. Be specific about your familiarity with Good Clinical Practice/ICH Guidelines and how your skills align with the job requirements.
Showcase Communication Skills: Since excellent communication and interpersonal skills are crucial for this role, provide examples in your application that demonstrate your ability to effectively communicate with site personnel and manage relationships.
Tailor Your Application: Customize your cover letter to reflect your enthusiasm for the position at Syneos Health. Mention why you are interested in working with them and how you can contribute to their mission of accelerating customer success.
Wie du dich auf ein Vorstellungsgespräch bei Syneos Health, Inc. vorbereitest
✨Understand the Regulatory Landscape
Make sure you are well-versed in Good Clinical Practice (GCP) and ICH guidelines. Be prepared to discuss how you have applied these regulations in your previous roles, as this will demonstrate your expertise and commitment to compliance.
✨Showcase Your Monitoring Experience
Highlight your previous monitoring experiences, especially any site qualification, initiation, and close-out visits you've conducted. Use specific examples to illustrate your ability to manage sites effectively and ensure protocol compliance.
✨Demonstrate Strong Communication Skills
Since the role requires excellent communication and interpersonal skills, practice articulating your thoughts clearly. Be ready to discuss how you have successfully liaised with site personnel and managed relationships in past projects.
✨Prepare for Technical Questions
Expect questions related to clinical data management and source document review. Brush up on your technical knowledge and be ready to explain how you verify data accuracy and completeness in case report forms.
