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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.
Job Responsibility
Act as PAREXEL's direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues
Build relationships with investigators and site staff
Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements
Evaluate on-site staff assignment, determine and implement corrective actions if necessary
Address and resolve issues at sites
Address/evaluate/resolve issues pending from previous visits
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 meetings and audits and regulatory inspections
Collect, review, and approve updated site documentation
Evaluate site recruitment plan and provide strategy for improvements
Perform on-site visits including Qualification and Initiation visits
Conduct remote visits/contacts as needed
Generate visit/contact report
Evaluate overall compliance and performance of sites
Assess and manage test article/study supply
Review and follow-up site payment status
Follow-up on CRF data entry, query status, and SAEs
Conduct on-site study-specific training if applicable
Perform site facilities assessments
Recognize impact of study non-compliance on study timelines
Ensure timely and accurate completion of project goals and update of applicable trial management systems
Work with team members to meet project goals
Update Clinical Trial Management Systems on an ongoing basis
Monitor and maintain compliance with ICH-GCP and applicable regulations
Delegate administrative tasks to Administrative Support Team as needed
Maintain a positive, results-oriented work environment
Maintain working knowledge of ICH-GCP Guidelines and Parexel SOPs
Ensure understanding of project scope, milestones, budgets
Provide input for Performance Development Conversations
Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Sound problem solving skills
Able to take initiative and work independently
Advance presentation skills
Client focused approach to work
Ability to interact professionally within a client organization
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 CTMS, EDMS, and MS-Office
Strong interpersonal, verbal, and written communication skills
Sense of urgency
Effective time management
Developing ability to work across cultures
Shows commitment to consistently high-quality work
Ability to work in a virtual team environment
Great attention to detail
Able to accommodate extensive travel time requirements
Holds a driver's license where required.
What we offer
Flexible work arrangements
Career growth and development through training, mentorship, and advancement programs