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Clinical Research Site Monitor (FSP) - Sponsor Dedicated

Italy, Remote Job ID R0000017234 Category Clinical Trials Date Posted 10/31/2023
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As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity.

Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

  • Communicator
  • Detail-oriented
  • Flexible
  • Organized
  • Problem-solver
  • Self-starter

About This Role

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.

Parexel FSP is currently seekingSite Monitors I/II in any location in Italy.As a Site Monitor, you would focus on monitoring at maintenance phase almost exclusively.

You would be dedicated to one sponsor, a global pharmaceutical company that leads the way in discovering and developing innovative health solutions that help prevent and treat diseases.

Our sponsor has a long history of excellence in research, delivering medicines, vaccines, and other health solutions for some of the most difficult diseases in the world.

Key Accountabilities

  • Ensuring regulatory, ICH-GCP and protocol compliance.

  • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates significant issues to the project team and develops action plans.

  • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company Standard Operating Procedures (SOPs)/processes

  • Per the Clinical Monitoring Plan (CMP) or SMP: Ability to conduct monitoring activities using different methods, (e.g., both on site and remote) where allowed by country regulations

  • Conducts source document review and verification of appropriate site source documents and medical records

  • Verifies required clinical data entered in the Case Report Form (CRF) is accurate and complete

  • Manages reporting of protocol deviations and appropriate follow up

  • Documents activities via follow up letters, monitoring reports, communication logs, and other required project documents as per SOPs and CMP and SMP

  • Conducts follow up for escalated adverse event monitoring (AEM) report queries

  • Collaborates with primary Site Manager who will act as the primary liaison with site personnel

The Individual

  • A minimum of 1 year experience as a clinical monitor with demonstrated experience of monitoring (virtual or onsite)

  • Bachelor’s degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience

  • Experience of utilizing systems like Siebel Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Investigator Site File (eISF) (Florence) OR can demonstrate skill sets that show they have agility to work with new systems to support monitoring practice

  • Proficiency in local language is required

  • English proficiency is required

  • Ability to manage required travel of on a regular basis


  • Networking and relationship building skills

  • Ability to communicate effectively and appropriately with internal and external stakeholders

  • Ability to adapt to changing technologies and processes

  • Effectively overcoming barriers encountered during the implementation of new processes and systems

  • Excellent communication (verbal and written), presentation, and interpersonal skills relating to colleagues and associates, both inside and outside of the organization

  • Identifies and builds effective relationships with investigator site staff and other stakeholders

  • Must demonstrate good computer skills and be able to embrace new technologies

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Potential Career Path

Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business.

  • CRA I
  • CRA II
  • Senior CRA
  • Project Management
    Subject Matter Expert
    People Management

Employee Insights


Female employee leaning on desk with Parexel logo in background Team photo
Larger team photo
Female employee with characters from an amusement park Female employee posing for a photo with beautiful landscape in the background
Team outing at laser tag Male employee with medical mask on sitting at desk with laptop open Team photo in an office setting

Why Clinical Research Associates work at Parexel

Learn About Our Culture

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