Senior Clinical Research Associate

Accountabilities:
The Senior Clinical Research Associate will be responsible for overseeing clinical monitoring activities, maintaining strong site relationships, and ensuring studies are conducted according to protocols, regulatory requirements, and quality standards. Perform and coordinate clinical monitoring activities in accordance with ICH-GCP guidelines, local regulations, and applicable standard operating procedures. Conduct site visits, including pre-study, initiation, interim monitoring, and close-out visits, ensuring protocol compliance and accurate documentation. Act as the primary contact for assigned clinical sites, developing collaborative relationships with investigators and site teams. Provide protocol training and study-related guidance to clinical research sites and project teams. Monitor site performance indicators, including enrollment progress, data entry quality, protocol deviations, and overall site issues. Review clinical data and support resolution of discrepancies, including Serious Adverse Event (SAE) reconciliation. Ensure patient safety and data integrity through effective monitoring practices and site education. Communicate site performance updates, risks, and opportunities to clinical study teams. Support study milestones, including site activation, recruitment, database activities, and study close-out. Assist with audit and inspection preparation, ensuring quality findings are addressed appropriately. Mentor and support less experienced clinical research associates when required. Participate in investigator meetings, booster visits, and other study-related activities as needed. Requirements: The ideal candidate should have strong clinical operations experience, excellent communication skills, and the ability to manage multiple priorities while maintaining compliance and quality standards in global clinical research environments. Bachelor’s degree in a relevant scientific discipline or equivalent qualification. Minimum of 3 years of clinical operations experience, including at least 2 years of clinical monitoring experience. Experience in pharmaceutical or biotechnology clinical trials is preferred. Previous experience with oncology and/or hematology studies is highly desirable. Strong knowledge of clinical trial processes, ICH-GCP guidelines, and applicable regulatory requirements. Experience managing clinical sites and ensuring protocol and regulatory compliance. Excellent written and verbal communication skills. Fluent English proficiency, both written and spoken, is required. Strong organizational skills with the ability to prioritize tasks and manage multiple projects simultaneously. Analytical mindset with attention to detail and commitment to data quality. Ability to build strong relationships with investigators, vendors, and cross-functional teams. Proficiency with Microsoft Office tools, including Word, Excel, PowerPoint, and Outlook. Familiarity with clinical trial management systems (CTMS) and data management platforms. Availability for frequent travel, with up to 70% travel expected. Benefits: Opportunity to work on innovative clinical research programs with global impact. Remote work flexibility. Exposure to international clinical operations and multidisciplinary teams. Professional growth opportunities within a science-focused environment. Participation in continuous learning and development initiatives. Opportunity to contribute to advancements in healthcare and patient outcomes. Collaborative workplace culture focused on excellence, inclusion, and innovation.

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