Clinical Research Site Monitor (FSP) - Sponsor Dedicated
Italy, Remote Job ID R0000017234 Category Clinical Trials Date Posted 10/31/2023Overview
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
Skills
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
#LI-REMOTE
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.
- APEX CRA
- CRA I
- CRA II
- Senior CRA
- Project ManagementSubject Matter ExpertPeople Management
Employee Insights
TEAM IMPRESSIONS
Why Clinical Research Associates work at Parexel
