Clinical Research Associate 2

Vor 2 Tagen

Berlin, Deutschland Veranex, Inc. Vollzeit

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.

**About This Role**:
Veranex has an exciting opportunity to join our team as a Clinical Research Associate. You will be part of a team working to improve lives globally through medical technology innovation. The Clinical Research Associate will be responsible for organizing and overseeing clinical studies and ensuring the studies are conducted, recorded, and reported in accordance with all applicable regulatory requirements, good clinical practice (GCP), the study protocol and standard operating procedures (SOPs).

**What You Will Do**:

- Acts as project resource to clinical site, sponsor, and internal stakeholders regarding the product under investigation and the clinical study conduct
- Supports study activities to meet protocol and client objectives, maintaining regulatory compliance and professional integrity for clinical studies
- Contributes to the development of study documentation, e.g., protocol, informed consent, case report form (CRF) and study specific plans (monitoring plans, data management plans) as well as annual progress reports (APRs) and the clinical study report (CSR).
- Manages and maintains the documentation of all clinical study activities in the study Trial Master File
- Confirms data quality/integrity by participating in site qualification and monitoring visits (site initiation, monitoring, and site close-out), reviewing adverse events and device deficiencies, reviewing data trending/metrics, reviewing audit reports, and implementing corrective actions as necessary
- Establishes regular lines of communication and assists with administration of protocol and related study training to assigned sites

**Qualifications**:
**Required skills**:

- Bachelors’ degree in life sciences or related discipline
- 2-4 years’ relevant work experience in the medical device field
- Strong knowledge of Good Clinical Practice (ISO 14155) and/or Good Study Practice (ISO 20916)
- Good knowledge of the European regulations MDR (EU 2017/745) and/or IVDR (EU 2017/746)
- Good written and oral communication skills in English
- Good organizational and time-management skills
- Excellent attention to detail
- Ability to multitask and prioritize work
- Good ability to work in cross-functional teams
- Able to travel (25-50%)

**Preferred**:

- Good knowledge in risk assessment
- Good knowledge in statistics
- Other languages such as French, German and Italian a plus
- Takes a proactive approach to work
- Good knowledge in cardiology
- IVD experience

  • Clinical Research Associate

    vor 2 Wochen

    Berlin, Deutschland Translational Research in Oncology Vollzeit

    If you are an experienced CRA who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you! - TRIO (Translational Research in Oncology) is an academic clinical research organization that is dedicated to advancing translational cancer research by pursuing forward innovative and targeted...

  • Clinical Research Associate

    vor 3 Wochen

    Berlin, Deutschland Worldwide Clinical Trials Vollzeit

    **Requisition Number** **6186** **Employment Type***: **Regular** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...

  • Clinical Research Associate, Germany

    vor 3 Wochen

    Berlin, Deutschland Worldwide Clinical Trials Vollzeit

    **Requisition Number** **6721** **Employment Type***: **Contractor** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...

  • Clinical Research Lead

    vor 2 Wochen

    Berlin, Deutschland Advanced Clinical Vollzeit

    The country Clinical Research Lead (CRL) responsibilities include operational delivery of strategic clinical studies assigned to the country, to support client';s pipeline, in accordance with ICH/GCP, client SOPs, local operating guidelines and local requirements, as applicable. CRL works locally, supporting Associate Director Clinical Operations (ADCO) /...

  • Senior Clinical Research Associate

    vor 1 Woche

    Berlin, Deutschland Worldwide Clinical Trials Vollzeit

    **Requisition Number**7835** **Employment Type**:Contractor** **Who we are** Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s...

  • Senior Clinical Research Associate

    vor 2 Wochen

    Berlin, Deutschland Worldwide Clinical Trials Vollzeit

    **Requisition Number**8065** **Employment Type**:Regular** **Who we are** Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s...

  • Contract Senior Clinical Research Associate

    vor 3 Wochen

    Berlin, Deutschland Ora Vollzeit

    **POSITION TITLE**: Senior Clinical Research Associate **DEPARTMENT**:Ora Europe **LOCATION**: Remote, Germany **Ora Values the Daily Practice of ** - Prioritizing Kindness - Operational Excellence - Cultivating Joy - Scientific Rigor_ At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug...

  • Clinical Research Associate

    vor 2 Wochen

    Berlin, Deutschland ProPharma Group Vollzeit

    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners...

  • Clinical Research Associate Ii

    vor 4 Wochen

    Berlin, Deutschland AL Solutions Vollzeit

    Clinical Research Associate II - Germany Jordan Griffiths is representing a leading global provider of outsourced drug and device development and commercialization services to pharmaceutical, biotechnology, medical device, and government organizations, and they are seeking an experienced Clinical Research Associate II to be based in Germany. In this role,...

  • Sr. Clinical Research Associate

    vor 2 Wochen

    Berlin, Deutschland Cmed Vollzeit

    The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany, Denmark, Sweden, UK, Romania, US, India and Czech Republic. Through CMED (a part of the Aixial...

  • Initiation Clinical Research Associate

    vor 2 Monaten

    Berlin, Deutschland Parexel Vollzeit

    The **Initiation Clinical Research Associate **(**iCRA**) specialises in performing all study start up activities for a clinical trial. You will participate in Pre SIV activities and be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. The iCRA can also support protocol amendments if applicable. This...

  • Apex Clinical Research Associate

    Vor 4 Tagen

    Berlin, Deutschland Parexel Vollzeit

    Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction. As a CRA...

  • Senior Clinical Research Associate

    vor 2 Monaten

    Berlin, Deutschland Worldwide Clinical Trials Vollzeit

    Requisition Number7836Employment Type:Regular Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific...

  • Senior Clinical Research Associate

    vor 4 Wochen

    Berlin, Deutschland Worldwide Clinical Trials Vollzeit

    Requisition Number7836Employment Type:Regular Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific...

  • Clinical Research Associate

    vor 4 Wochen

    Berlin, Deutschland IGES Institut Vollzeit

    Die Clinische Studien Gesellschaft (CSG) ist eine renommierte Full-Service Contract Research Organisation mit Sitz in Berlin. Unser Schwerpunkt liegt in der europaweiten Durchführung klinischer Studien und Beobachtungsstudien für Arzneimittel, Medizinprodukte und digitale Gesundheitsanwendungen in allen Indikationsgebieten. Als CRO der IGES Gruppe...

  • Clinical Research Associate Ii

    vor 3 Wochen

    Berlin, Deutschland Sitero LLC Vollzeit

    Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our...

  • Senior Clinical Research Associate

    vor 2 Monaten

    Berlin, Deutschland Worldwide Clinical Trials Remote-Arbeit Freiberufler Vollzeit

    Requisition Number7835Employment Type:Contractor Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific...

  • Senior Clinical Research Associate

    vor 4 Wochen

    Berlin, Deutschland Worldwide Clinical Trials Remote-Arbeit Freiberufler Vollzeit

    Requisition Number7835Employment Type:Contractor Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific...

  • Karrierechancen: Clinical Regulatory Associate

    Vor 5 Tagen

    Berlin, Deutschland BIOTRONIK SE & Co. KG Vollzeit

    Clinical Regulatory Associate (m/w/d) BIOTRONIK ist einer der weltweit führenden Hersteller kardio - und endovaskulärer Implantate und Katheter für Herzrhythmusmanagement, Elektrophysiologie und Vaskuläre Intervention. Als weltweit tätiges Unternehmen mit Hauptsitz in Berlin entwickeln, produzieren und vertreiben wir qualitativ höchstwertige...

  • Karrierechancen: Clinical Regulatory Associate

    Vor 5 Tagen

    Berlin, Deutschland BIOTRONIK Vollzeit

    Clinical Regulatory Associate (m/w/d) BIOTRONIK ist einer der weltweit führenden Hersteller kardio - und endovaskulärer Implantate und Katheter für Herzrhythmusmanagement, Elektrophysiologie und Vaskuläre Intervention. Als weltweit tätiges Unternehmen mit Hauptsitz in Berlin entwickeln, produzieren und vertreiben wir qualitativ höchstwertige...