CRA - Client-dedicated, NLD
NL Zeist FSP Amersfoort NL
4 dagen geleden

Job Description

Clinical Research Associate Client-dedicated Netherlands

We are vital links betweenan idea for a new medicine and the people who need it. We are the people of PPD thousands of employees in locations worldwide connected by tenacity andpassion for our purpose : to improve health.

You will be joining atruly collaborative and winning culture as we strive to bend the time andcost curve of delivering life-saving therapies to patients.

Our team is expanding, andwe are looking to recruit a CRA to be dedicated to one client only, using andworking with their systems, SOPs and monitoring only client’s studies.

Responsibilities include but are not limited to :

  • Monitoring independently different sites, including RBM.
  • Participation in investigator meeting as necessary
  • Ensuring the trial is conducted in accordance with the approved protocol ICH-GCP guidelines, SOPs etc
  • Ensuring effective communication between investigational sites and internal / external stakeholders
  • Working on project work and initiatives for process improvement as required
  • Requirements

    Educationand Experience :

  • Degree in pharmacy, life science or related field
  • Experience in a pharmaceutical, biotech or CRO company
  • Independent clinical monitoring experience
  • Oncology trials experience
  • Fluency in English and Dutch
  • Ability to work at least 80%
  • Knowledge,Skills and Abilities :

  • Demonstrated understanding of medical / therapeutic area knowledge and medical terminology
  • Excellent understanding and demonstrated application of GCPs and applicable SOPs
  • Management of regulatory and / or IEC questions
  • Development and preparation of the local informed consent form
  • Effective oral and written communication skills, with the ability to communicate effectively with medical personnel
  • Management of the delivery of study supplies
  • Strong customer focus
  • Effective interpersonal skills
  • Strong attention to detail
  • Effective organizational and time management skills
  • Proven flexibility and adaptability
  • Ability to work in a team or independently as required
  • Good computer skills : good knowledge of Microsoft Office and the ability to learn appropriate software
  • Good presentation skills
  • What we offer :

    At PPD we hire the best, developourselves and each other, and recognise the power of being one team. We understandthat you will want to grow both professionally and personally throughout yourcareer, and therefore at PPD you will benefit from an award-winning learningand development programme, ensuring you reach your potential.

    As well as being rewardeda competitive salary, we have an extensive benefits package based around thehealth and well-being of our employees.

    We have a flexible working culture, where PPDtruly value a work-life balance. We’ve grown sustainably year on yearbut continue to offer a collaborative environment, with teams of colleagueseager to share expertise and have fun together.

    We are a globalorganisation but with a local feel.

    Some benefits include :

  • Annual salaryreviews
  • Company paidpension contribution
  • Medical insurance
  • Life insurance
  • 25 days annualleave + 12 additional days
  • Opportunities tojoin various social initiatives
  • We have a strong will towin - We earn our customer’s trust - We are gamechangers - We do the rightthing -We are one PPD -
  • If you resonate with ourfive principles above, and ultimately wish to accelerate the delivery of safeand effective therapeutics for some of the world’s most urgent health needs,then please submit your application we’d love to hear from you.

    Please note that due tothe high volume of applications, only short-listed candidates will becontacted.

    PPD is an equal employer.

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