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Clinical Research Associate II - FSP (Kraków/Wrocław/ Silesia)

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

Bachelor’s degree in biological science, pharmacy or health-related discipline, Minimum 2 years of independent field monitoring experience, Understanding of clinical trials methodology and terminology, Knowledge of ICH GCP Compliance, Current driver’s license required.

Key responsabilities:

  • Set up and oversee studies independently
  • Complete study status reports and maintain documentation
  • Assist in submission for ethics/IRB approval
  • Prepare regulatory submissions as required
  • Manage multiple tasks while meeting project timelines
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Parexel XLarge http://www.parexel.com/
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Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Do you know why we are one of only three CROs to have received the Leadership Award for 11 consecutive years? Because we appreciate our team, whose dedication and commitment to excellence is reflected in this award, and we work with heart, keeping the patient at the center of everything we do.

Join our team and develop your career with us by contributing your personal and professional talents and skills. Together we will continue to do things that matter to people.

Parexel FSP is looking for CRA in Poland to strengthen our clinical operations team. Work from home and with the flexibility you want. Our CRAs have less travel and less workload to maintain work-life balance. We offer long-term projects, world-class technology and training tailored to your individual experience.

As a CRA, you will work independently and will be responsible for all activities required to set up and oversee a study, complete study status reports, and maintain study documentation. You will participate in the submission of protocols, consent documents for ethics/IRB approval and assist in the preparation of regulatory submissions as requested.

You will have the opportunity to be a unique sponsor dedicated to one of the top 10 pharmaceutical companies in the world, working on oncology studies that deliver real impact.

We’ll expect you to have:

  • Bachelor’s or equivalent degree in biological science, pharmacy or other health related discipline.
  • Minimum of 2 years of active independent field monitoring experience - all types of visits.
  • Site Management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
  • Ability to perform all clinical monitoring activities independently.
  • Strong interpersonal, written, and verbal communication skills within a matrixed team.
  • Experience working in a self-driven capacity, with a sense of urgency and limited oversight.
  • A client-focused approach to work and flexible attitude with respect to assignments/new learning.
  • The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s).
  • An honest and ethical work approach to promote the development of life changing treatments for patients.
  • Understanding of ICH GCP Compliance.
  • Excellent time management and social skills
  • Highly motivated with a phenomenal eye for detail.
  • Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week
  • Current driver’s license required

Benefits of working with Parexel FSP:

  • Premium salary.
  • Car.
  • Paid holidays.
  • Medical care plan: Health, Dental & Vision.
  • Life Assurance.
  • Company cell phone and equipment.
  • Market leading PTO.
  • Culture of teamwork and collaboration.
  • People who motivate and face challenges together.
  • Innovative technology.
  • Excellent training.

Send me your updated resume to marta.kuniewicz@parexel.com for an immediate interview.

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Pharmaceuticals
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Time Management
  • Detail Oriented
  • Verbal Communication Skills
  • Social Skills

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