Inhouse Clinical Research Associate with French 1

il y a 1 mois

Machelen, Belgique Boston Scientific Temps plein

Additional Locations: Belgium-Diegem

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

The Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO’s mission of building a world class shared clinical technology, process innovation and clinical operations team, in partnership with the company’s divisions, through technology enablement, high-touch customer service, study acceleration, and high-quality data collection.

Driving principles and behaviors for this role are collaboration, accountability, innovation, adaptability, integrity and caring.

 

Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the CRA conducts clinical trial site start-up activities related to the preparation and approval of regulatory documents, ensuring they are conducted consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures. Specifically, these activities will include:

  • Ethics Committee (EC) submissions and approvals.
  • Site informed consent form (ICF) customizations & negotiations.
  • Essential regulatory document collection.
  • Collaboration with Regulatory Affairs for Competent Authority (CA) submissions and approvals and other site start-up support activities, as applicable.

 

 The CRA also provides support in enrollment, follow-up, and closure of clinical trial activities.

 

 

Your responsibilities will include:

  • Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites.
  • Manage multiple sets of essential regulatory documents across several studies and division portfolios.
  • Partner with clinical sites to support the negotiation and customization of Informed Consent Form (ICF)
  • Develop and foster clinical research site relationships to become a subject matter expert in the site start up regulatory process across multiple studies.
  • Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives.
  • Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking.
  • Manage and problem solve site start up challenges that arise to mitigate impact to service level agreement and study goals.
  • Develop, prepare, complete and track required regulatory, ICF and legal documentation.
  • Document clinical research site and investigator readiness for participation across multiple studies
  • Support internal quality audits, regulatory inspections, as applicable.
  • Update and maintain study-specific startup and close out trackers.
  • Update and maintain site specific metrics in Clinical Trial Management Systems, file and maintain site documents in eTMFs.
  • Provide updates to leadership on site start up activities, investigator readiness, regulatory submission, approval status, etc.
  • Escalate challenges and/or initiate outreach to Principal investigators, clinical research site coordinator, divisional clinical study leads and/or other stakeholders when appropriate.
  • Ensure compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WI, policies & procedures.

 

 

What we are looking for in you:
Minimum Qualifications

  • Bachelor’s Degree, or an equivalent combination of experience and education.
  • 4-5 years experience in a CRA role
  • Experience in study submissions to the Ethics Committee.
  • Fluency (written and spoken)in French & English and conversational  Dutch. Any additional languauge is a plus.
  • Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast-paced environment.
  • Ability to work in a team environment and possess clear, concise communication & presentation skills – written and verbal.
  • Must be comfortable interacting with clinical research site personnel via phone, email, and in person.

 

Preferred Qualifications

  • Research Coordinator or In-House Clinical Research Associate / Clinical Research Associate /Study Start up specialist experience.
  • Experience working with Ethic Committee’s.
  • Experience working with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems / eTMF.

 

This role offers weekly hybrid working mode and can be based from any BSC hub location across Europe.  

 

Requisition ID: 594532

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you

  • Inhouse Cra

    il y a 3 jours

    Machelen, Belgique Oxford Global Resources Temps plein

    For one of our clients, a medical device company based in Machelen, we are looking for an enthusiastic Inhouse CRA to come on board and join the team to cover sites located in Flanders and in the Netherlands. This position is open for bilingual candidates Dutch and English, with a first experience in clinical research. This opportunity is hybrid working :...

  • Inhouse Cra

    il y a 4 jours

    1830 Machelen, Belgique Oxford Global Resources Temps plein

    For one of our clients, a medical device company based in Machelen, we are looking for an enthusiastic Inhouse CRA to come on board and join the team to cover sites located in Flanders and in the Netherlands. This position is open for bilingual candidates Dutch and English, with a first experience in clinical research. Job Description The Inhouse Clinical...

  • Inhouse Cra

    il y a 4 jours

    Machelen, Belgique Oxford Global Resources Temps plein

    For one of our clients, a medical device company based in Machelen, we are looking for an enthusiastic Inhouse CRA to come on board and join the team to cover sites located in Flanders and in the Netherlands. The Inhouse Clinical Research Associate (Inhouse CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities...

  • Inhouse CRA

    il y a 4 jours

    Machelen, Belgique Oxford Global Resources Temps plein

    For one of our clients, a medical device company based in Machelen, we are looking for an enthusiastic Inhouse CRA to come on board and join the team to cover sites located in Flanders and in the Netherlands. This position is open for bilingual candidates Dutch and English, with a first experience in clinical research. This opportunity is hybrid working :...

  • Inhouse Cra

    il y a 4 jours

    1830 Machelen, Belgique Oxford Global Resources Temps plein

    For one of our clients, a medical device company based in Machelen, we are looking for an enthusiastic Inhouse CRA to come on board and join the team to cover sites located in Flanders and in the Netherlands. This position is open for bilingual candidates Dutch and English, with a first experience in clinical research. This opportunity is hybrid working : ...

  • Inside Sales Associate with Dutch

    Il y a 6 mois

    Machelen, Belgique Arrow Electronics, Inc. Temps plein

    **Position**: Inside Sales Associate with Dutch As **Arrow Global Components **(AGC), a part of Arrow Electronics, we are a leader in distribution and value-added services related to electronic components. We resell, customize, and distribute electronic components to our clients all over the world. Our business is based on a trusted, long-lasting net of...

  • Agent Inhouse Sales

    il y a 2 jours

    1830 Machelen, Belgique Start People Office Leuven Temps plein

    Description Our customer offers a wide range of different products and services and each of your shipment will be handled with care and professionality. There services cover moving general cargo, perishables, dangerous goods and pharma. They are looking for an Agent Inhouse Sales & Customer Service. You will be part of the team responsible for selling their...

  • Agent Inhouse Sales

    il y a 4 semaines

    Machelen, Belgique Start People Office Leuven Temps plein

     DescriptionOur customer offers a wide range of different products and services and each of your shipment will be handled with care and professionality. There services cover moving general cargo, perishables, dangerous goods and pharma.  They are looking for an Agent Inhouse Sales & Customer Service. You will be part of the team responsible for selling...

  • Clinical IT Solutions Commercial Lead

    il y a 4 semaines

    Machelen, Belgique Solventum Temps plein

    **3M Health Care is now Solventum** At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the...

  • Associate Specialist, Technical Support

    Il y a 6 mois

    Machelen, Belgique Abbott Laboratories Temps plein

    Abbott is recruiting an Associate Specialist, Technical Support to be based in our Distribution Center in Machelen, Belgium. **ROLES & RESPONSIBILITIES** - Resolves escalated customer issues where known or typical solutions cannot resolve problem. - Escalates complex cases to Tier 2 Technical Support or to his/her direct manager. - Documents, updates, and...

  • Customer Service Representative with Dutch, French

    il y a 3 semaines

    Machelen, Belgique Solventum Temps plein

    **3M Health Care is now Solventum** **At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the...

  • Clinical It Solutions Commercial Lead

    il y a 4 jours

    1830 Machelen, Belgique Solventum Temps plein

    Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear...

  • Customer Service Representative With Dutch, French And English

    il y a 1 semaine

    Machelen, Belgique Solventum Temps plein

    Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear...

  • Customer Service Representative With Dutch, French And English

    Il y a 3 mois

    1830 Machelen, Belgique Solventum Temps plein

    Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear...

  • Emploi: agent de service

    il y a 2 jours

    1830 Machelen, Belgique Start People Office Leuven Temps plein

    Description Our customer offers a wide range of different products and services and each of your shipment will be handled with care and professionality. There services cover moving general cargo, perishables, dangerous goods and pharma. They are looking for an Agent Inhouse Sales & Customer Service. You will be part of the team responsible for selling their...

  • Agent Inhouse Sales

    il y a 1 mois

    Machelen, Belgique Start People Office Leuven Temps plein

     DescriptionOur customer offers a wide range of different products and services and each of your shipment will be handled with care and professionality. There services cover moving general cargo, perishables, dangerous goods and pharma.  You will be part of the team responsible for selling their products and services within Belgium. You are an...

  • Customer Service Employee with SAP and Incoterms

    Il y a 6 mois

    Machelen, Belgique Robert Half Belgium Temps plein

    Robert Half is currently looking for a customer service employee (M/F/x) with knowledge of SAP and INCOTERMS. This position could either be a 70%, 80%, 90% or a full time. Robert Half is currently looking for a customer service employee (M/F/x) with knowledge of SAP and INCOTERMS. This position could either be a 70%, 80%, 90% or a full time. It concerns an...

  • Lead Solution Architect with Affinity with Red Hat

    Il y a 4 mois

    Machelen, Belgique Devoteam Temps plein

    Devoteam is a leading consulting firm focused on digital strategy, tech platforms and cybersecurity. By combining creativity, tech and data insights, we empower our customers to transform their business and unlock the future. With 25 years’ experience and 10,000 employees across Europe, the Middle East and Africa, Devoteam promotes responsible tech for...

  • Data Scientist Engineer

    il y a 2 semaines

    Machelen, Belgique Devoteam Temps plein

    Company Description Devoteam is a leading consulting firm focused on digital strategy, tech platforms and cybersecurity. By combining creativity, tech and data insights, we empower our customers to transform their business and unlock the future. With 25 years’ experience and 10,000 employees across Europe, the Middle East and Africa, Devoteam promotes...

  • Commercial Team Leader

    il y a 4 jours

    1830 Machelen, Belgique Solventum Temps plein

    On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. In the interim, our Privacy Policy here: // As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity,...