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Initiation Clinical Research Associate I

Mexico - Any Region - Home Based Date posted 05/12/2022 Job ID 81079BR

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. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.

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

Parexel is looking for an Initiation Clinical Research Associate to join our team in Mexico!

Working as an Initiation Clinical Research Associate (ICRA) you will be the direct point of contact with assigned sites located throughout North and South America and accountable for quality and delivery during the start-up phase. Duties will include preparation, negotiation, and facilitation of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments, Informed Consent Forms (ICF); Conduct remote Qualification Visits (QVs), Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
To be considered for this opportunity you must have clinical trials experience as a CRA, study nurse or site coordinator ideally with a university degree in a health-related discipline. Understanding of GCP and relevant regulations plus knowledge of submissions and ICF customizations is expected. This is a virtual team environment and your strong interpersonal and communication skills will help you to succeed. Fluency in English is required

Additional duties will include:
• Build relationships with investigators and site staff.
• Conduct, drive and manage country-specific feasibility and/or site prequalification and qualification activities, which may include: o Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments. o Conduct remote Qualification Visits (QVs).
• Generate visit/contact reports, using judgment to identify site issues and problem-solving to direct resolution.
• Develop a strategy to configure, distribute, and collect, and review and approve, high-quality country-specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
• 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 and MoH/RA (if applicable) 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; Patient recruitment & retention.
• Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
• Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.
• 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

Qualifications :
Experience/Education:
  • Significant regulatory and/or site experience in clinical trials
  • Educated to degree level preferred (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience
  • Sound awareness of all relevant regulations, including GCP
  • Fluency in English is required

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