Clinical Research Associate II
il y a 3 semaines
We are seeking a highly motivated and experienced Clinical Research Associate II to join our team in France. As a Clinical Research Associate II, you will be responsible for managing clinical trials from site identification to close-out, ensuring timely and accurate completion of project goals and updating applicable trial management systems.
Key Responsibilities:- Manage clinical trials from site identification to close-out, ensuring timely and accurate completion of project goals and updating applicable trial management systems.
- Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
- Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
- 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 as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.
- Show commitment and perform consistent high quality work.
- Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.
- Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
- Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.
- 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, with limited need for oversight.
- Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.).
- 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; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Strong computer skills including but not limited to the 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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