Senior Clinical Research Associate

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

📋 Description

• Execute studies at designated sites as an engaged member of local study teams.

• Work in collaboration with Project Management Clinical Operations, Study Start-Up, Clinical Study Assistants, and other Clinical Research Associates (CRAs) to fulfill country-level study obligations.

• Serve as the primary point of contact with study sites and oversee study execution to ensure proper delivery and adherence to compliance.

• Choose, initiate, monitor, and conclude assigned clinical study sites in accordance with Alexion policies, ICH-GCP, and local regulations.

• Conduct selection, initiation, interim monitoring, and closeout visits, both remotely and on-site.

• Execute remote data checks following study-specific Clinical Monitoring Plans.

• Enhance site performance and address or escalate study-related challenges.

• Educate, support, and guide investigators and site personnel, particularly on Risk-Based Quality Management principles.

• Formulate recruitment strategies and manage/support enrollment to meet designated milestones.

• Track study Key Performance Indicators (KPIs), including action item aging, Source Data Verification (SDV), data entry, query aging, and monitoring visit report metrics.

• Prepare and finalize monitoring visit reports in the Clinical Trial Management System (CTMS) and provide prompt feedback and follow-up communications to Principal Investigators.

• Gather and upload essential documents into the electronic Trial Master File (eTMF) and assist with regular quality-control checks of the eTMF.

• Aid in study startup and regulatory upkeep, including the preparation, review, tracking, and submission of documents to Ethics Committees/Institutional Review Boards (EC/IRB) and Regulatory Authorities when necessary.

• Participate in the nomination and selection of investigators and support feasibility assessments.

• Collaborate with Medical Affairs, Medical Advisor Pipeline, and other internal stakeholders.

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

• Prepare for and engage in audits and regulatory inspections.

⛳️ Requirements

• At least 4 years of CRA monitoring experience.

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

• Strong understanding of international guidelines, particularly ICH-GCP.

• Fundamental knowledge of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).

• In-depth knowledge of applicable local regulations.

• Solid medical knowledge and a capability to grasp relevant Alexion Therapeutic Areas.

• Good comprehension of the drug development process.

• Thorough understanding of clinical study management, including monitoring, handling study drugs, and data management.

• Exceptional attention to detail.

• Outstanding written and verbal communication abilities.

• Strong collaboration and interpersonal skills.

• Proficient negotiation skills.

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

• A valid driving license.

• Capability to work with remote collaborators and navigate a matrix reporting structure.

• Ability to adapt positively to change.

• Skill in identifying more efficient and effective methods for delivering high-quality clinical trials.

• Capacity to prioritize and manage multiple tasks with competing deadlines.

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

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

• Team-oriented and adaptable; quick to respond to changing demands and opportunities.

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

🏝️ Benefits

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

• Accommodation for disabilities and special needs available through the application process.