Clinical Research Associate (CRA II/Senior) - Ophthalmology
New
P
ParexelClinical research
United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- At least 18 months of direct onsite monitoring experience as a Clinical Research Associate.
- Required Skills
- Microsoft ExcelRelationship management
Requirements
- Have at least 18 months of direct onsite monitoring experience as a Clinical Research Associate.
- Have ophthalmology clinical trial monitoring experience.
- Hold a bachelor's degree or equivalent in biological science, pharmacy, or another health-related discipline.
- Know Good Clinical Practice, applicable regulatory requirements, and clinical trial processes.
- Have experience using a Clinical Trial Management System and an Electronic Document Management System.
- Have experience using Microsoft Office applications, including Excel and Word.
- Demonstrate site relationship management, problem-solving, and communication skills.
- Be able to work independently with urgency and limited oversight.
- Be able to manage multiple priorities, evaluate changing scenarios, apply study protocols, and meet project timelines.
- Demonstrate attention to quality and detail and the ability to collaborate with internal and external stakeholders.
Responsibilities
- Conduct qualification, site initiation, monitoring, and termination visits at assigned clinical sites, and prepare timely visit and contact reports.
- Manage site quality and delivery from site identification through closeout.
- Serve as the primary point of contact for assigned clinical sites, answering questions and resolving issues.
- Oversee study integrity and build effective relationships with investigators and site staff.
- Review trial performance and help safeguard study participants' rights, safety, and well-being in accordance with the protocol.
- Develop patient recruitment strategies with clinical sites to support enrollment timelines.
- Ensure compliance with standard operating procedures, study protocols and amendments, Good Clinical Practice, and applicable regulatory requirements.
- Evaluate reported data quality and integrity, site performance, and investigational product accountability.
- Monitor regulatory documentation for completeness and quality, and perform site document verification.
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