Clinical Research Associate I-FSP
Taipei, Taiwan Job ID R0000027497 Category Clinical Trials Date Posted 09/18/2024Overview
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
Key Accountabilities:
• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH GCP guidelines.
• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.
• Reviews and verifies accuracy of clinical trial data collected, either on site or remotely.
• Provides regular site status information to team members, trial management, and updates trial management tools.
• Completes monitoring activity documents as required by SOPs or other contractual obligations.
• Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
• Escalates site and trial related issues per SOPs until identified issues are resolved or closed.
• Performs essential document site file reconciliation. • Performs source document verification and query resolution.
• Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites.
• Verifies SAE reporting according to trial specifications and ICH GCP guidelines.
• Communicates with investigative sites.
• Updates applicable tracking systems.
• Ensures all required training is completed and documented.
• Serves as main observer/assessor of site activities.
• Facilitates audits and audit resolution.
• To undertake other reasonably related duties as may be assigned from time to time as appropriate for experience and as required e.g., protocol amendment submissions, Investigator site budget negotiation.
Skills:
• Proven organizational and presentation skills.
• Ability to manage multiple tasks and meticulous attention to detail.
• Agile & quick learner, good team player
• Willingness and ability to train others on study administration procedures.
• Excellent written and verbal communication skills.
• Good written and spoken English.
• Computer Proficiency: ability to handle daily work via Microsoft Word, Excel, PowerPoint, and Outlook, etc.
Knowledge and Experience:
• 1 - 2 years clinical monitoring experience required. CRAs with less experience may be considered based on level of mentoring available.
• Read, write, and speak fluent English; fluent in host country language required.
• Oncology experience preferred.
• a licensed healthcare professional (i.e., registered nurse); or equivalent work experience required.
Education:
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution.
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
