Lead CRA: Elevate Site Performance & Enrollment

CORXEL Pharmaceuticals; Michigan; Vor Ort; USD 95.000 - 140.000; Vollzeit

Zusammenfassung

Corxel Pharmaceuticals is seeking a Senior Clinical Research Associate / Lead CRA to oversee high-priority clinical trial sites across North America. The role acts as the primary sponsor contact for assigned sites, building strong investigator relationships and driving high-quality study execution.

The position requires extensive experience in site qualification, initiation, ongoing monitoring, data quality review, and risk-based mitigation, with regular travel to sites in the Midwest and beyond.

Qualifikationen

• Bachelor's degree in life sciences, nursing, pharmacy, or related discipline.
• Significant clinical research monitoring experience in biotech, pharma, or CRO.
• Experience independently managing clinical trial sites through initiation, monitoring, and close-out.
• Strong working knowledge of ICH-GCP, FDA requirements, and clinical trial regulations.
• Ability to build effective relationships with investigators and site teams.
• Experience identifying site-level risks and driving issue resolution.

Aufgaben

• Provide oversight for site monitoring and ensure protocol compliance.
• Conduct site qualification, initiation, routine monitoring, and close-out activities.
• Review source data, consent forms, eligibility, and data quality.
• Identify site risks and drive corrective actions.
• Monitor enrollment and site performance with defined metrics.
• Collaborate with investigators and site teams to optimize enrollment.

Kenntnisse

ICH-GCP knowledge

FDA regulatory knowledge

Clinical site management

Relationship management

Communication skills

Willingness to travel

Ausbildung

Bachelor's degree in life sciences or related

Tools

EDC systems

CTMS

eTMF systems

Jobbeschreibung

Corxel Pharmaceuticals is seeking a Senior Clinical Research Associate / Lead CRA to oversee high-priority clinical trial sites across North America. The role acts as the primary sponsor contact for assigned sites, building strong investigator relationships and driving high-quality study execution.

The position requires extensive experience in site qualification, initiation, ongoing monitoring, data quality review, and risk-based mitigation, with regular travel to sites in the Midwest and beyond.