Senior Clinical Research Associate

This is a fully remote position, open to applicants in Florida, +1 more state.

📋 Description

• Actively participate in local study teams to deliver assigned clinical studies at designated sites.

• Work collaboratively with Project Management Clinical Operations, Study Start-Up, Clinical Study Assistants, CRAs, and Country Operations Management.

• Serve as the primary liaison with study sites while overseeing study conduct to ensure proper delivery and compliance.

• Select, initiate, monitor, and close assigned sites in accordance with Alexion procedures, ICH-GCP, and local regulations.

• Conduct selection, initiation, interim monitoring, and closeout visits, both remotely and onsite.

• Execute remote data checks in line with study-specific Clinical Monitoring Plans.

• Enhance site performance and address or escalate study-related issues as necessary.

• Train, support, and advise investigators and site staff, particularly regarding RBQM principles.

• Develop site recruitment strategies and manage/enhance enrollment milestones.

• Track study KPIs, including action-item aging, SDV, data entry, query aging, and monitoring-visit report metrics.

• Prepare and finalize monitoring visit reports in CTMS, providing timely feedback and follow-up letters to Principal Investigators.

• Collect and upload essential documents to the eTMF, assisting with regular eTMF quality-control checks.

• Aid in study start-up and regulatory maintenance tasks, including document preparation, review, tracking, and submissions to EC/IRB and Regulatory Authorities when necessary.

• Contribute to investigator nomination, selection, and feasibility assessments.

• Collaborate with Medical Affairs, MAP, and other internal stakeholders.

• Report systematic or significant quality issues, data privacy breaches, and ICH-GCP compliance concerns.

• Prepare for and collaborate on audits and regulatory inspections.

⛳️ Requirements

• At least 4 years of CRA monitoring experience.

• Bachelor’s degree in a relevant field, preferably in life sciences, or equivalent qualification.

• Strong knowledge of international guidelines, including ICH-GCP.

• Basic understanding of GMP/GDP.

• Comprehensive knowledge of applicable local regulations.

• Good medical knowledge with the capacity to learn about relevant Alexion Therapeutic Areas.

• Solid understanding of the drug development process.

• Exceptional understanding of Clinical Study Management, including monitoring, study drug handling, and data management.

• Keen attention to detail.

• Outstanding written and verbal communication skills.

• Strong collaboration and interpersonal skills.

• Good negotiation abilities.

• Flexibility in scheduling and a willingness to travel; travel may reach up to 70% during peak periods.

• Valid driving license.

• Capability to work with remote teams and within a matrix reporting structure.

• Positive adaptability to change.

• Ability to identify more efficient and effective processes for delivering high-quality clinical trials within budget and time constraints.

• Proficiency in prioritizing and managing multiple tasks with competing deadlines.

• Proactive and assertive communication with both internal stakeholders and sites.

• Understanding of technology's impact on projects and expertise in utilizing/developing computer skills in an e-enabled environment.

• Team-oriented and adaptable; capable of responding swiftly to changing demands and opportunities.

• Experience across all study phases and in rare medical conditions is preferred.

🏝️ Benefits

• An inclusive environment that provides equal employment opportunities for all applicants and employees.

• Disability and special-needs accommodations available through the application form.