Clinical Research Associate II Job at Parexel (Taipei)

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, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites
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 if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up
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 updated/amended site documentation
Evaluate site recruitment plan in collaboration with the site staff
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 including supply, accountability and destruction/return status
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 international and local regulations
Delegate administrative and other tasks to Administrative Support Team
Maintain a positive, results-orientated work environment
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs
Ensure basic understanding of project scope, milestones, budgets
Provide input and feedback for Performance Development Conversation(s)
Proactively keep manager informed about work progress and any issues
Develop expertise to become a subject matter expert
Work in a self-driven capacity
Complete additional tasks in a timely manner

Requirements

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 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
Shows commitment to and performs consistently high-quality work
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

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Clinical Research Associate II

Job Description

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