Aktuelle Jobs im Zusammenhang mit Clinical Research Associate - Hannover, Niedersachsen - Edwards Lifesciences
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Clinical Research Associate
vor 2 Wochen
Hannover, Niedersachsen, Deutschland Edwards Lifesciences VollzeitJob Title: Clinical Research AssociateEdwards Lifesciences is seeking a highly motivated and detail-oriented Clinical Research Associate to join our team in Germany. As a Clinical Research Associate, you will be responsible for conducting clinical studies and ensuring the overall integrity of study implementation and adherence to study protocol at assigned...
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Clinical Research Associate
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Hannover, Niedersachsen, Deutschland Edwards Lifesciences VollzeitJob Title: Clinical Research AssociateEdwards Lifesciences is seeking a highly motivated and detail-oriented Clinical Research Associate to join our team in Germany. As a Clinical Research Associate, you will be responsible for conducting clinical studies and ensuring the overall integrity of study implementation and adherence to study protocol at assigned...
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Hannover, Niedersachsen, Deutschland Edwards Lifesciences VollzeitJob Title: Clinical Research AssociateEdwards Lifesciences is seeking a highly skilled Clinical Research Associate to join our team in Germany. As a Clinical Research Associate, you will be responsible for remotely supporting field clinical research associate/site activities to ensure the overall integrity of study implementation and adherence to study...
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Hannover, Niedersachsen, Deutschland Edwards Lifesciences VollzeitJob Title: Clinical Research AssociateEdwards Lifesciences is seeking a highly skilled Clinical Research Associate to join our team in Germany. As a Clinical Research Associate, you will be responsible for remotely supporting field clinical research associate/site activities to ensure the overall integrity of study implementation and adherence to study...
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Clinical Research Associate Medizintechnik
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Clinical Research Engineer
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Research Associate Position
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Research Associate Position
vor 3 Wochen
Hannover, Niedersachsen, Deutschland Leibniz Universität Hannover VollzeitResearch Associate PositionWe are seeking a highly skilled Research Associate to join our team at the Institute of Design and Building Construction. As a Research Associate, you will be involved in teaching various courses and preparing and carrying out individual research projects.Your RoleThe successful candidate will be responsible for:Teaching courses in...
Clinical Research Associate
vor 2 Monaten
Position Overview:
We are seeking a Clinical Research Associate II or Senior Clinical Research Associate with a minimum of 3 years of monitoring experience to join our team in Germany or surrounding areas. The ideal candidate will be proficient in conducting Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs) independently.
Key Qualifications:
The candidate should possess a comprehensive understanding of the regulatory landscape, including ISO, MDR, and GCP. Familiarity with maintaining Investigator Site Files (ISFs) and the Trial Master File (TMF) is essential. A background in pharmaceuticals or medical devices, particularly in cardiology or cardiac therapy clinical trials, is preferred. Ideal locations include North or Central Germany.
Responsibilities:
The Clinical Research Associate will be responsible for providing remote support to field clinical research associates and site activities to ensure the integrity of study implementation and adherence to the study protocol at assigned clinical sites. Key responsibilities include:
- Organizing and overseeing clinical studies, including assisting and conducting clinical monitoring activities.
- Serving as the primary contact for assigned clinical sites throughout the study process.
- Accountability for achieving and reporting on agreed clinical milestones.
- Supporting the study team in interactions with Ethics Committees and Competent Authorities.
- Actively participating in project team meetings as required.
- Collaborating closely with internal stakeholders to ensure proper project execution.
- Providing training to site and Edwards personnel, including preparation and maintenance of study documents and understanding of required examinations.
- Reporting on site enrollment progress, including device accountability and protocol deviations.
- Processing adverse events and documenting procedural case observations.
- Identifying and reporting adverse events and device-related complications in compliance with regulatory requirements.
- Supporting process improvement initiatives and ensuring audit readiness for internal and external audits.
- Performing other incidental duties as assigned by management.
Education and Experience:
A Bachelor's Degree in a related field is required, along with 3 years of relevant medical device and/or clinical experience. Preferred qualifications include clinician experience in intra-operative procedures from a Registered Nursing Degree curriculum or similar roles.
Additional Skills:
Candidates should possess strong computer skills in MS Office Suite and the ability to operate general office machinery. Excellent written and verbal communication skills, along with good problem-solving and critical thinking abilities, are essential. Adherence to company policies and protocols, including environmental health and safety measures, is expected.
Work Environment:
At Edwards Lifesciences in Germany, we are committed to creating a diverse and inclusive workplace where all employees can thrive. We offer competitive compensation and benefits, flexible working hours, and a comprehensive wellness program, among other advantages.
