Lead Senior CRA: Site Leadership & Enrollment

CORXEL Pharmaceuticals; Michigan; Ibrido; USD 90.000 - 140.000; Tempo pieno

Descrizione del lavoro

Corxel Pharmaceuticals seeks an experienced Senior Clinical Research Associate / Lead CRA to oversee high-priority clinical trial sites across North America. You will act as sponsor contact for sites, foster investigator relationships, ensure quality study execution, and proactively address barriers to enrollment and data integrity.

The role emphasizes monitoring, risk-based approaches, and cross-functional collaboration with clinical operations, data management, safety, and regulatory teams.

Competenze

• Bachelor's degree in life sciences, nursing, pharmacy, or related discipline.
• Significant clinical research monitoring experience in biotech/pharma/CRO.
• Experience managing clinical trial sites through initiation, monitoring, and close-out.
• Strong knowledge of ICH-GCP, FDA requirements, and monitoring best practices.
• Proven ability to build relationships with investigators and site teams.
• Experience identifying site-level risks and driving timely resolutions.
• Excellent written and verbal communication; highly organized.

Mansioni

• Site Monitoring and Oversight: conduct qualification, initiation, routine and remote monitoring, close-out as applicable.
• Ensure compliance with protocol, monitoring plan, ICH-GCP, regulations, and procedures.
• Review source docs, informed consent, eligibility, accountability, safety reporting, essential documents, and data quality.
• Identify site risks, document findings, drive corrective actions, and maintain inspection-ready files.
• Monitor enrollment performance, screen potential patients, and work with sites to improve enrollment.
• Support onboarding of new sites based on enrollment potential and feasibility.
• Establish strong relationships with investigators, study coordinators, and site stakeholders.
• Coordinate with internal teams to ensure consistent execution across North American sites.

Conoscenze

Site Monitoring

Sponsor Liaison

ICH-GCP

FDA Regulations

Communication

Willingness to Travel

Formazione

Bachelor's degree in life sciences or related

Strumenti

EDC Systems

CTMS

Descrizione del lavoro

Corxel Pharmaceuticals seeks an experienced Senior Clinical Research Associate / Lead CRA to oversee high-priority clinical trial sites across North America. You will act as sponsor contact for sites, foster investigator relationships, ensure quality study execution, and proactively address barriers to enrollment and data integrity.

The role emphasizes monitoring, risk-based approaches, and cross-functional collaboration with clinical operations, data management, safety, and regulatory teams.