Initiation Clinical Research Associate

2 months ago


Southeast Fairbanks, United States Parexel Full time

The Initiation Clinical Research Associate II (iCRA) specializes in Pre SIV activities will be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. The iCRA can also support protocol amendments if applicable. Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.

Knowledge and Experience:
- Substantial Site Management / site initiation / SSU-start up experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.

Key skills:
- Able to take initiative and work independently, and to proactively seek guidance when necessary.
- Excellent presentation and problem-solving skills.
- Ability to interact professionally within a client organization, maintaining a client focused approach to work.
- 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.
- Strong ability to make appropriate decisions in ambiguous situations.
- 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.
- Excellent interpersonal, verbal, and written communication skills.
- Sense of urgency in completing assigned tasks and ability to assist others to meet study/ country deliverables.
- Excellent time management in order to meet study needs, team objectives, and department goals.
- Proven 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.
- Act as a mentor and role model for other team members.
- Effectively enlist the support of team members in meeting goals.
- Attention to detail.

Education:
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.

#LI-REMOTE



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