Senior Regional Clinical Research Associate

Site Communications & Relationship Management

• Draft and deliver confirmation, follow-up, and monitoring visit reports (SQV, SIV, IMV, COV)
• Maintain regular communication with the Lead RCRA (LRCRA) to report on site progress and resolve issues
• Assess site readiness and resourcing (personnel, facilities, supplies) for trial conduct
• Collaborate with vendors (e.g., central lab, imaging core) to resolve operational issues
• Lead or participate in co-monitoring, oversight, and training visits as needed

Preferred Skills, Qualifications and Technical Proficiencies:

• Strong organizational and time management skills; capable of managing multiple priorities and deadlines
• Excellent written and verbal communication skills; adept in regulatory and clinical terminology
• Proven problem-solving and analytical skills
• Leadership experience with the ability to mentor and train junior CRAs
• Proficiency in Microsoft Word, Excel, and PowerPoint
• In-depth knowledge of FDA regulations and industry practices
• Willingness to travel up to 80% regionally, with occasional cross-country travel

Preferred Education and Experience:

• 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
• Familiarity with ICH-GCP guidelines and the ability to assess medical data

The pay range that the Company reasonably expects to pay for this position is $125,300 – $165,800; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

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 Applicants must be currently authorized to work in the United States on a full-time basis.