Clinical Research Associate II
il y a 2 jours
Parexel is seeking a highly skilled Clinical Research Associate II to join our team in France. As a key member of our site management team, you will be responsible for ensuring the successful execution of clinical trials at assigned sites.
Key Responsibilities- Site Identification and Qualification
- Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the site qualification phase.
- Build relationships with investigators and site staff.
- Conduct, drive, and manage country-specific feasibility and/or site pre-qualification and qualification activities.
- Site Activation and Maintenance
- 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.
- Study Management and Compliance
- Ensure timely and accurate completion of project goals and update of applicable trial management systems.
- Work with team members to meet project goals, provide strategy for efficient project planning and goal completion.
- Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
- Communication and Collaboration
- Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections.
- Proactively keep manager informed about work progress and any issues.
- 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, and to proactively seek guidance when necessary.
- 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.
- 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 and ability to assist others to meet study/country deliverables.
- Effective time management in order to meet study needs, team objectives, and department goals.
- 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.
- Able to accommodate travel time requirements, according to tasks allocation/phase of the study assigned.
- Attention to detail.
- Holds a driver's license where required.
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
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