In-House Clinical Research Associate
New
R
Rho IncClinical Research
United StatesFull-TimeMiddle
Salary55,000 - 65,000 USD per year
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Job Details
- Experience
- At least 1 year of direct work experience
Requirements
- Bachelors Degree in a life science, nursing or pharmacy field
- At least 1 year of direct work experience managing essential documents within the CRO, pharma or biotech industry
- Good knowledge of clinical research process
- Understanding of Regulatory and Central/Local ethic submission processes for assigned countries
- Working knowledge of current ICH GCP guidelines and applicable regulations
- Strong communication skills (written, verbal, and presentation)
- Attention to detail
- Critical thinking and analytical skills
- Ability to work in an agile and adaptable environment
Responsibilities
- Collect, track and review investigational site records relating to subject screening and enrollment
- Assist in the development of study plans and status reports
- Collect, track, and review all site regulatory documents
- Assist with development and review of Informed Consent Forms
- Interact with sites, clients, vendors and internal study team members
- Maintain the clinical trials management system (CTMS) and other project tracking tools
- Track study supplies and coordinate shipments of supplies to sites as needed
- Manage the study Trial Master File (TMF) and ensure periodic TMF audits
- Coordinate work with CRAs monitoring on-site
- Perform on site co-monitoring and remote monitoring activities
- Perform regular reviews of data entered by investigational site staff according to data review/monitoring guidelines
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