Role OverviewAs a Senior Clinical Research Associate, you will lead monitoring operations for clinical trials, ensuring adherence to protocols, regulatory requirements, and quality standards. You will work independently and in coordination with cross-functional teams across the US and EU to support trial execution, mentor junior staff, and maintain compliance with ICH GCP, FDA, and local regulations.
Key Responsibilities
- Lead and support Clinical Research Associates through guidance, performance feedback, and mentoring to ensure compliance with study timelines, budgets, and standard operating procedures.
- Plan and conduct qualification, initiation, interim, and close-out visits—both remotely and on-site—with thorough documentation and follow-up.
- Review monitoring reports, source data, and case report forms to verify accuracy and completeness, ensuring data integrity and protocol compliance.
- Oversee site regulatory documentation, including ethics approvals and contract coordination, and support audit readiness activities.
- Collaborate with data management and clinical operations teams to resolve data discrepancies and support adverse event reporting and reconciliation.
- Develop study-specific monitoring plans and training materials as needed, and contribute to the maintenance of the Clinical Trial Management System (CTMS).
- Facilitate communication between sponsors, investigative sites, and internal teams to resolve issues and align on project goals.
- Support new hire onboarding and training, promoting consistency and knowledge sharing within the CRA team.
- Manage project budgets and billing coordination for stand-alone monitoring assignments.
- Participate in internal and client-facing meetings, contributing insights on site performance, enrollment progress, and risk mitigation.
Qualifications
- US Candidates: Bachelor’s degree in life sciences or related field; minimum 3 years in pharma/biotech/CRO with at least 2 years in clinical monitoring and 1 year in team leadership.
- EU Candidates: Graduation in a scientific health discipline; minimum 2 years of autonomous monitoring experience; certification as a Monitor per Italian CRO decree (for Italy); proficiency in local language and English.
- Demonstrated expertise in ICH GCP, FDA regulations, and local regulatory requirements.
- Strong organizational, analytical, and problem-solving skills, with the ability to manage multiple priorities in a dynamic setting.
- Proficiency in clinical trial databases, electronic data capture systems, and CTMS platforms.
- Excellent communication skills and a customer-focused approach in building relationships with sites and sponsors.
- Willingness and ability to travel as required by study needs.
Work Environment
This role is based in Ukraine, with monitoring activities conducted both remotely and on-site. The position supports a flexible work model that emphasizes collaboration across time zones and geographic boundaries. Team members operate in a self-directed yet cooperative environment, guided by core values of accountability, integrity, inclusivity, and mutual growth.
Culture & Values
- Decisions and interactions are guided by courage, honesty, and personal accountability.
- The team fosters inclusion and actively elevates the contributions of others.
- Open dialogue and idea-sharing are encouraged, with structured support for professional development and mentorship.
