Sr. In-House CRA
RemoteUnited States
Job Summary
Triage questions and requests from site staff regarding enrollment, documentation, and meeting arrangements using knowledge of study protocols and Good Clinical Practices. Independently collect, review, maintain, and track essential documents, then upload them to the trial master file while assessing completeness and regulatory compliance. Communicate and coordinate with internal and site staff, complete IRB/EC submissions, and update the Clinical Trial Management System with trial progress. Provide mentorship to junior staff, assist in audit preparation, and track issue and action item resolution to completion. Monitor site recruitment efforts, screen logs, and database currency, resolving data queries as needed. Prepare meeting agendas and minutes, review informed consent forms prior to IRB submission, and conduct or assist with remote and on-site monitoring visits.
Required Qualifications
- Bachelor's Degree Scientific discipline preferred, or directly applicable work experience preferred Required
- 1-3 years of relevant clinical research experience, (as a CTA, in-house CRA, study coordinator, etc.) Required
- Proficient with MS Office Suite High
- Excellent computer and organizational skills High
- High attention to detail required High
- Ability to work on varying projects and exercise critical thinking High
- self starter who can work independently and a team player who can work cross functionally with limited oversight High
- Knowledgeable in clinical research operations, including interpretation and implementation of country specific regulations and ICH guidelines, as required High
- Excellent organizational, interpersonal, and communication skills both oral and written High
- Demonstrated problem solving skills, self motivated, and adaptable to a dynamic environment High
- Knowledgeable in prioritization, problem solving, organization, critical thinking, decision making, time management, and planning activities High
- Ability to collaborate with internal and external colleagues and work well in a team oriented setting High
Desired Qualifications
- Bachelor's Degree Scientific discipline preferred
- directly applicable work experience preferred
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