Clinical Research Associate II - Multi-Sponsor Job at Parexel (Milan)

Job Description

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.

Job Responsibility

Act as PAREXEL's direct contact with assigned sites
Build relationships with investigators and site staff
Facilitate and support site with access to relevant study systems
Evaluate if on-site staff assignment is still accurate
Address and resolve issues at sites
Follow-up on and respond to appropriate site related questions
Apply working knowledge to identify and evaluate potential data quality and data integrity issues
Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required
Collect, review, and approve updated/amended site documentation
Evaluate site recruitment plan
Perform on-site visits including Qualification and Initiation visits
Conduct remote visits/contacts as requested/needed
Generate visit/contact report
Evaluate overall compliance and performance of sites and site staff
Assess & manage test article/study supply
Review & follow-up site payment status
Follow-up on CRF data entry, query status, and SAEs
Conduct on-site study-specific training
Perform site facilities assessments
Recognize impact of study non-compliance/issues/delays/changes on study timelines

Requirements

Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Close to at least 2 years independent monitoring experience in a similar setting
Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Sound problem solving skills
Able to take initiative and work independently
Advance presentation skills
Client focused approach to work
Flexible attitude with respect to work assignments and new learning
Ability to prioritize multiple tasks and achieve project timelines
Willingness to work in a matrix environment
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
Strong interpersonal, verbal, and written communication skills
Sense of urgency in completing assigned tasks
Effective time management
Developing ability to work across cultures
Ability to successfully work in a ('virtual') team environment
Great attention to detail
Able to accommodate extensive travel time requirements
Holds a driver's license where required

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Clinical Research Associate II - Multi-Sponsor

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