Description
We are seeking an experienced CRA to perform monitoring and site management work to ensure that sites are conducting studies and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.
Responsibilities
- Perform site monitoring visits in accordance with contracted scope of work and Good Clinical Practice
- Work with sites to adapt, drive, and track subject recruitment plans
- Administer protocol and related study training to assigned sites
- Evaluate the quality and integrity of study site practices
- Manage the progress of assigned studies
- Ensure site documents are available for filing in the Trial Master File
- Create and maintain documentation regarding site management and monitoring visit findings
- Collaborate with study team members for project execution support
Qualifications
- Bachelor's Degree in a scientific discipline or healthcare
- At least 2 years of on-site monitoring experience
- Good knowledge of clinical research regulatory requirements, including Good Clinical Practice and International Conference on Harmonization guidelines
- Computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint
- Written and verbal communication skills, including good command of English
- Organizational and problem-solving skills
- Effective time and financial management skills