ICON Strategic Solutions Clinical Research Associate - Vaccines - Remote, USA in Boston, Massachusetts
This position can be filled by a level 2 or level 3 Clinical Research Associate, based on the level of experience and qualifications of candidates being considered.
The Clinical Research Associate 2/3 (CRA2/3) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
Applies knowledge of ICON’s policies and procedures
Demonstrates excellent written and oral communication
Demonstrates excellent knowledge of ICH/GCP
Displays ability to manage investigative sites to facilitate trial deliverables
Demonstrates ability to escalate issues appropriately
Conducts monitoring to confirm subject safety and data integrity
Describes and demonstrates the principals of IP accountability
Identifies scientific misconduct at the site level
Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms
Mentors CRAs new to the position or company
Serves as an observation visit leader
Conducts monitoring evaluation visits
Assists team lead in the development of trial tools or documents
Assists with CTM tasks
Participates in the development of process changes/improvements
Presents at client meetings/Investigator meetings
Provides training to trial teams
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
Read, write and speak fluent English; fluent in host country language required.
2 years of experience supporting clinical trials including 1 year of on-site monitoring experience (for CRA2); 4 years of experience supporting clinical trials including 3 years of on-site monitoring experience (for CRA3)
Ability to travel for approximately 10 site visits each month
Proven success monitoring fast paced trials with quick turnaround times for database lock
High proficiency with Microsoft Office and company collaboration applications
Advanced skill in utilization of applicable clinical systems
Experience in monitoring all trial components (PSSV to COV) is preferred
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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Posted Date 3 months ago (8/29/2022 8:29 AM)
Location : Location US-Remote
ICON Strategic Solutions
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