Senior Clinical Research Associate (Sr CRA)
Role Overview
This position plays a central role in managing and supervising clinical trial monitoring operations across international sites. The Senior CRA ensures adherence to study protocols, regulatory requirements, and internal standards while providing strategic oversight and mentorship to junior team members. With a focus on quality, compliance, and operational efficiency, this role supports the successful execution of clinical development programs.
Key Responsibilities
- Lead and supervise CRA teams, offering guidance on project timelines, budget alignment, and standard operating procedures
- Conduct and coordinate qualification, initiation, interim, and close-out visits—both onsite and remotely—with thorough documentation
- Review monitoring reports, perform co-monitoring, and evaluate site performance to ensure protocol fidelity
- Support the creation of study-specific monitoring plans and contribute to training materials
- Verify source data accuracy and maintain integrity of case report forms through detailed review
- Oversee collection and quality control of regulatory documents and eTMF/TMF components
- Manage investigational product accountability and conduct site regulatory binder audits
- Collaborate with cross-functional teams to resolve clinical, operational, and contractual issues
- Ensure compliance with ICH GCP, FDA regulations, and sponsor-specific requirements
- Prepare and deliver billing updates to finance departments as needed
- Act as primary point of contact for sponsors in stand-alone monitoring projects
- Support adverse event tracking and reconciliation of serious adverse events with source records
- Participate in internal and client-facing meetings, contributing insights on site progress and risk mitigation
- Mentor new CRAs and assist in onboarding and training initiatives
- Contribute to the development and maintenance of Clinical Trial Management Systems (CTMS)
- Proactively identify site-level challenges and implement corrective strategies
- Maintain consistent communication with investigative sites to track enrollment and resolve queries
Qualifications
Applicants must demonstrate a solid foundation in clinical research with proven leadership capabilities. Requirements vary by region:
- United States: Bachelor’s degree in life sciences or related field; minimum 3 years in pharma/biotech/CRO with at least 2 years of monitoring experience and 1 year in team leadership. Must have permanent authorization to work in the U.S. and fluency in English.
- European Union (Italy): Graduation in a scientific health discipline, minimum 2 years of monitoring experience with autonomy in managing site activities, and certification as a Monitor per Italian CRO decree (15 Nov 2011). Must be fluent in the local language.
All candidates must show strong organizational and analytical skills, the ability to manage multiple priorities under pressure, and experience with electronic data capture systems and clinical databases. A commitment to ethical standards, attention to detail, and the capacity to navigate unstructured challenges are essential.
Work Environment
This is a hybrid role with flexibility to work across the U.S. and EU (Italy). The organization supports flexible work arrangements and encourages global travel as needed. Team members thrive in a collaborative, values-driven culture that emphasizes accountability, inclusion, and continuous learning.
Company Values
- Act with courage and integrity
- Take ownership of outcomes
- Communicate honestly and respectfully
- Foster inclusivity and psychological safety
- Support and elevate colleagues
- Embrace innovation and open dialogue
Professional Growth
The role offers opportunities for professional development, international engagement, and meaningful impact within a dynamic clinical research environment.
