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Initiation Clinical Research Associate II

Taipei, Taiwan Date posted 05/30/2021 Job ID 70548BR

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


  • 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.


Job Description
o Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase
o Conduct, drive and manage country specific feasibility activities, which may include: Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments
o Configure, distribute, collect, review, and approve (Sr. iCRA) high quality country specific and/or site specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation
o Customize, review, and negotiate as required country/site specific Informed Consent Forms (ICF), translations (in accordance with country/regulatory/client requirements), and any amendments
o Prepare and submit IRB/IEC application in accordance with country/regulatory/client requirements, following up until receipt of final approval
o Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy
o Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner as indicated per project requirements


* Excellent presentation skills
* Client focused approach to work
* Ability to interact professionally with external customers
* Flexible attitude with respect to work assignments and new learning
* Advanced ability to manage multiple and varied tasks with enthusiasm
* Attention to detail
* Ability to work in a matrix and virtual team environment and to value the importance of teamwork
* Strong computer skills including but not limited to the knowledge of Clinical Trial Management Systems (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word
* Excellent interpersonal, verbal, and written communication skills
* Advanced problem-solving skills
* Sense of urgency in completing assigned tasks
* Excellent time management in order to meet daily metrics, team objectives and department goals
* Proven ability to work across cultures
* Excellent ability to work independently but seek guidance when necessary
* Excellent ability to influence and negotiate resolutions and outcomes with sites and IRBs/IECs
* Willing and able to travel locally and internationally occasionally as required
* Education: Educated to degree level (biological science, pharmacy, or other health-related discipline preferred), nursing or other relevant qualification/experience

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