Clinical Research Associate
Sirtex
Bonn Germany
vor 15 Tg.

Sirtex is a global life-sciences company that develops and delivers effective oncology treatments using novel small particle technology. .

The global Sirtex team over the past few years has grown significantly and we now have almost 300 employees located in 20 countries.

Sirtex employees are driven by a passion to help medical professionals worldwide provide real hope for patients and their families.

Achieving this vision is a large and complex task requiring dedication and commitment.

The Role :

  • Ensures timely and accurate study-related communication to clinical personnel
  • Assists the Clinical Operations Manager and Clinical Research Managers in tracking of study activities
  • Works with the clinical sites to collect and file regulatory documentation required for the study
  • Ensure TMF and ISF set up and maintenance for global clinical studies
  • Coordinates specified clinical trial meetings (e.g., investigator meetings, Study Management Team meetings CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes
  • Sets-up and maintains audit-ready clinical trial documentation and study status
  • Manages and tracks : regulatory / IRB / EC / REB documentationsafety Letter distribution,confidentiality Disclosure Agreementsclinical trial insurance certificatesother clinical trial documents
  • Assists with quality assurance audits and resolution of audit findings
  • Sources clinical trial supplies through external vendors (such as Case Report Forms, Study Manuals, Lab Kits, )
  • Assists in developing of Investigator and Institution contracts and budget template, negotiates budgets with sites and arranges site payments
  • Coordinate site contracts negotiation and organize the investigator payments to sites
  • Requirements :

  • Bachelor’s degree or equivalent
  • Minimum of 4 years of clinical trial experience and previous CTA experience
  • Understanding of GCPs, ISO, ICH guidelines and regulatory requirements
  • Study coordinator, data management, site monitoring and / or nursing experience
  • CCRA preferred
  • Excellent communication skills and the ability to build effective relationships with trial centre staff and colleagues
  • Fluent English and good German language knowledge
  • Numeracy and an eye for detail
  • Good organizational, IT and administrative skills
  • Ability to travel up to 20% of the time within EMEA
  • What you can expect from Sirtex :

    If you have the right skills and experience and want to work for a company making a real difference to the quality of people’s lives, Sirtex will offer the right candidate :

  • Diverse and flexible employment and working arrangements to achieve the optimum balance between work and personal responsibilities and objectives
  • A working culture of respect, diversity and performance to help facilitate an inclusive culture
  • Attractive compensation and benefit packages which are practical, robust, fair and equitable
  • A place to grow through training opportunities
  • To apply, please email your cover letter and resume and all relevant certificates in English to Ecaterina Chislari, HR Generalist EMEA at recruitment sirtex-europe.com.

    Unfortunately, applications send via post cannot be returned

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