Senior Regional Clinical Research Associate
New
C
CorceptBiotechnology
Location: RemoteFull-TimeSenior
Salary125,300 - 165,800 USD per year
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Job Details
- Experience
- 6+ years of clinical trial experience, including at least 4 years as a regional field-based CRA
- Required Skills
- GCPMicrosoft ExcelPowerPoint
Requirements
- Bachelor’s degree in science, healthcare, or nursing.
- 6+ years of clinical trial experience, including at least 4 years as a regional field-based CRA.
- In-depth knowledge of FDA regulations and industry practices.
- Familiarity with ICH-GCP guidelines and ability to assess medical data.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Strong organizational and time management skills.
- Excellent written and verbal communication skills.
- Leadership experience with the ability to mentor and train junior CRAs.
- Willingness to travel up to 80% regionally, with occasional cross-country travel.
Responsibilities
- Conduct qualification, initiation, interim, and close-out visits both remotely and on-site.
- Act as the main point of contact for site staff and ensure consistent communication.
- Monitor site performance, including recruitment, enrollment, source data verification, and protocol adherence.
- Train site staff on protocol requirements, source documentation, and CRF completion.
- Prepare and submit visit reports and correspondence in accordance with the monitoring plan.
- Manage and maintain regulatory documentation, including ISF and eTMF reconciliation.
- Oversee Investigational Product accountability, reconciliation, and storage conditions.
- Collaborate with external vendors to resolve operational issues.
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