Clinical Research Associate Job at Parexel

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.

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
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
Ensure sites are compliant with project specific training requirements
Evaluate on-site staff assignment
Address and resolve issues at sites
Follow-up on and respond to appropriate site related questions
Apply working knowledge and judgment 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
Collect, review, and approve (if applicable) updated/amended site documentation
Evaluate site recruitment plan
Perform on-site visits (Qualification and Initiation visits)
Conduct remote visits/contacts as requested
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
Ensure timely and accurate completion of project goals and update of applicable trial management systems
Work with team members to meet project goals
Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis
Ensure that assigned sites are audit and inspection ready
Monitor and maintain compliance with ICH-GCP and applicable regulations
Delegate administrative tasks to Administrative Support Team
Maintain a positive, results-orientated work environment
Maintain a working knowledge of applicable guidelines and regulations
Ensure basic understanding of project scope, milestones, budgets
Provide input for Performance Development Conversation(s)
Proactively keep manager informed
Develop expertise to become a subject matter expert
Work in a self-driven capacity
Complete additional tasks in a timely manner

Requirements

Minimum 1 year as a clinical monitor with demonstrated experience of monitoring (virtual & onsite)
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Proficiency in local language preferred
English is required
Sound problem solving skills
Able to take initiative and work independently
Advance presentation skills
Client focused approach
Ability to interact professionally within a client organization
Flexible attitude
Ability to prioritize multiple tasks and achieve project timelines
Willingness to work in a matrix environment
Strong computer skills including knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office
Strong interpersonal, verbal, and written communication skills
Sense of urgency
Effective time management
Developing ability to work across cultures
Ability to successfully work in a (‘virtual’) team environment
Consulting Skills
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
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

Parexel - All Job Offers

Select Country

Clinical Research Associate

Job Description

Job Responsibility

Requirements

What we offer

Looking for more opportunities?

Clinical Research Associate

Clinical Research Associate

Clinical Research Associate

Clinical Research Associate

Clinical Research Associate

Clinical Research Associate

Clinical Research Associate

Clinical Research Associate

Clinical Research Associate

Our AI answers in your language