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Senior Initiation Clinical Research Associate

Germany - Any Region - Home Based Date posted 05/09/2021 Job ID 69825BR

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

Act as PAREXEL’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
  • Build relationships with investigators and site staff.
  • Conduct, drive and manage country specific feasibility and/or site prequalification and qualification activities, which may include: Confidentiality Agreements (CDA) o Conduct remote Qualification Visits (QVs).
  • Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents (SRP)
  • Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
  • Prepare and submit IRB/IEC application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
  • Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
  • Forecast, develop, manage, and revise plans and strategies for: IRB/IEC and MoH / RA submission/approval; Site activation
  • Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
  • Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start.

Qualifications

Problem solving skills.
  • Able to work independently, seeking/taking guidance when necessary.
  • Sound presentation skills.
  • Client focused approach to work.
  • Flexible attitude with respect to work assignments and new learning.
  • Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply understanding of study protocol(s)
  • Willingness to work in a matrix environment and to value the importance of teamwork.
  • Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
  • Sound interpersonal, verbal, and written communication skills in English. Portuguese will be also valorated.
  • Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
  • Developing ability for effective time management in order to meet study needs, team objectives, and department goals.
  • Developing ability to work across cultures.
  • Shows commitment to and performs consistently high quality work.
  • Ability to successfully work in a (‘virtual’) team environment.
  • Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
  • Attention to detail.
  • Holds a driver’s license where required
Knowledge and Experience:
  • Previous relevant work experience preferred.
Education:
  • Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.

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