Sr. Clinical Research Associate

CORXEL Pharmaceuticals; Michigan; Presencial; USD 95 000 - 140 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

ICH-GCP knowledge

FDA regulatory knowledge

Clinical site management

Relationship management

Communication skills

Willingness to travel

Formação académica

Bachelor's degree in life sciences or related

Ferramentas

EDC systems

CTMS

eTMF systems

Descrição da oferta de emprego

We are seeking an experienced Senior Clinical Research Associate / Lead CRA to provide direct oversight for high-priority clinical trial sites across North America.

The successful candidate will serve as the primary sponsor contact for assigned sites, build strong relationships with investigators and site teams, ensure high-quality study execution, and proactively address operational barriers that may affect patient identification, enrollment, data quality, or protocol compliance.

Preferred location: central Michigan, Chicago.

Responsibilities

• Site Monitoring and Oversight
• Conduct site qualification, initiation, routine monitoring, remote monitoring, and close-out activities, as applicable.
• Ensure site compliance with the clinical trial protocol, monitoring plan, ICH-GCP requirements, applicable regulations, and company procedures.
• Review source documentation, informed consent documentation, eligibility confirmation, investigational product accountability, safety reporting, essential documents, and data quality.
• Identify site-level risks, document findings, and drive timely corrective and preventive actions.
• Maintain accurate, complete, and inspection-ready monitoring documentation and reports.
• Enrollment and Site Performance
• Partner closely with investigators and site teams to improve study awareness, patient identification, screening, and enrollment.
• Develop site-specific action plans to address enrollment barriers and operational challenges.
• Monitor site performance using agreed metrics, including enrollment activity, screening patterns, data quality, issue resolution, and investigator engagement.
• Provide hands-on support to sites and proactively escalate risks that could affect study timelines or patient recruitment.
• Support evaluation and onboarding of additional sites based on enrollment potential, operational readiness, investigator engagement, hospital capacity, and activation feasibility.
• Investigator and Site Relationship Management
• Establish trusted, productive relationships with principal investigators, study coordinators, research nurses, pharmacists, and other site stakeholders.
• Serve as a visible and responsive sponsor representative for assigned sites.
• Maintain frequent communication with site teams and provide timely follow-up on operational, clinical, and enrollment-related issues.
• Strengthen relationships with high-performing and high-potential research centers, particularly within the Midwest and other priority North American regions.
• Facilitate effective communication between sites and internal medical, clinical operations, data management, safety, and regulatory teams.
• Suppliers and Cross-Functional Collaboration
• Work closely with the suppliers while maintaining clear accountability for Corxel-managed sites.
• Coordinate monitoring activities, issue escalation, data review, site communications, and operational handoffs with supplier teams.
• Participate in study team meetings and provide clear updates on site performance, enrollment progress, risks, and mitigation actions.
• Collaborate with internal and external stakeholders to ensure consistent execution across the broader North American site network.

Lead CRA Responsibilities

For candidates hired at the Lead CRA level, additional responsibilities may include:

• Provide functional guidance, coaching, and day-to-day support to other CRAs.
• Promote consistent monitoring practices and quality standards across assigned sites.
• Review site performance trends and recommend prioritization or escalation strategies.
• Support monitoring-plan implementation, risk-based monitoring activities, and inspection-readiness initiatives.
• Coordinate regional coverage and help balance CRA workload across priority sites.
• Serve as a senior operational point of contact for complex site issues.
• Contribute to study-level planning, process improvement, and lessons learned.

Required Education/Qualifications/Skills:

• Bachelor's degree in life sciences, nursing, pharmacy, or a related discipline.
• Significant clinical research monitoring experience within a biotechnology, pharmaceutical, or CRO environment.
• Demonstrated experience independently managing clinical trial sites through initiation, routine monitoring, and close-out.
• Strong working knowledge of ICH-GCP, FDA requirements, clinical trial regulations, and monitoring best practices.
• Proven ability to build effective relationships with investigators and clinical research site teams.
• Experience identifying site-level risks and driving issues through timely resolution.
• Strong written and verbal communication skills.
• Excellent organization, prioritization, documentation, and follow-through.
• Ability and willingness to travel regularly to assigned sites.

Preferred

• Experience supporting Phase II or Phase III interventional clinical trials.
• Experience in cardiometabolic studies is a plus.
• Experience working with high-enrolling academic medical centers and hospital-based research sites.
• Experience supporting enrollment acceleration or site performance improvement initiatives.
• Familiarity with risk-based monitoring, electronic data capture systems, clinical trial management systems, and electronic trial master files.
• For the Lead CRA level, previous experience mentoring CRAs or coordinating regional monitoring activities with at least 6 years of experience as a CRA.
• For the Sr. CRA, candidates should have at least 4 years of experience as a CRA.

What Success Looks Like

• Assigned sites receive responsive, high-quality sponsor oversight.
• Investigator and site-team relationships are strong and productive.
• Enrollment barriers are identified early and addressed with practical action plans.
• Monitoring findings and data-quality issues are resolved within appropriate timelines.
• Site performance, risks, and mitigation actions are clearly communicated to the study team.
• Assigned sites remain compliant, inspection-ready, and focused on high-quality study execution.

Why Join Corxel

This is an opportunity to take a highly visible sponsor-side role in a strategically important clinical program. The Senior CRA / Lead CRA will have direct influence on site engagement, enrollment performance, study quality, and the successful delivery of a priority North American clinical trial.

Corxel values scientific rigor, operational ownership, proactive collaboration, and a patient-focused approach to clinical development.

Corxel Pharmaceuticals is an equal opportunity employer. We are committed to creating an inclusive workplace and consider qualified applicants without regard to legally protected characteristics.