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Senior Clinical Research Associate (FSP)

Poland - Any Region - Home Based Date posted 10/10/2021 Job ID 75306BR

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 at Parexel, you‘ll be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter—people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

Success Profile

Check out the top traits we’re looking for and see if you have the right mix.

  • Innovative
  • Problem-Solver
  • Communicator
  • Tech-Savvy
  • Confident
  • Independent
  • "The last 4.5 years I had a steep learning curve and I am still learning via on-the-job challenges and solid management feedback. Next to my personal growth, I also enjoy our open atmosphere and the great collegiality."

    Stefanie – Sr Clinical Research Associate

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Compensation

    Competitive salaries and bonus structure based on individual metrics.

Responsibilities

As a Senior Clinical Research Associate (SCRA) at Parexel FSP you will be joining a team with a wide variety of experiences and knowledge. We’re looking for people like you to take the initiative to do things better and smarter people who want to grow personally and professionally. We recognize and uphold the importance of all people, the way we do things, our quest for innovation, and most importantly, our patients.

You will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on oncology studies that deliver real impact.

Parexel FSP will offer you world class technology and training catered to your individual experience. You can anticipate less travel and a lower protocol load in comparison to industry peers.

If impact, flexibility, and career development appeal to you, Parexel could be your next home.

Position Purpose:
The Senior Clinical Research Associate (SCRA) will act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Primary Duties:
  • Coordinates & manages various tasks to achieve Site Ready.
  • Participates & provides inputs on site selection and validation activities.
  • Performs remote and on-site monitoring & oversight activities using various tools.
  • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records visit & non-visit contact reports.
  • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
  • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
  • Manages and maintains information and documentation in Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF) and various other systems.
  • Supports and/or leads audits/inspection activities as needed.
  • Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.

Qualifications

Skills and Education:
  • B.A./B.S. preferred with a strong emphasis in science and /or biology.
  • Minimum 4 years of direct site management & monitoring experience gained within bio/pharma/ or CRO required.
  • Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
  • Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
  • Fluent in local languages and English (verbal and written) and excellent communication skills.

About Parexel FSP:
A global provider of functional service solutions across a range of specialized disciplines for clinical development and biopharmaceutical product lifecycle support including clinical operations, biometrics, safety, regulatory, medical writing, and medical affairs.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

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