Senior Clinical Research Associate

🔥 17 hours ago

🐊 Florida, Illinois – Remote

🐊 Florida – Remote 🌽 Illinois – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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AstraZeneca

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 Post-IPO Debt on 2023-02

Healthcare • Biotechnology • Pharmaceuticals

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines. It primarily works in areas of oncology, cardiovascular, renal & metabolism, and respiratory diseases. With operations in over 100 countries, AstraZeneca is dedicated to scientific research and a commitment to providing effective treatments and improving patient health across a wide array of conditions.

📋 Description

• Deliver allocated clinical studies at assigned sites as an active participant in local study teams • Collaborate with Project Management Clinical Operations, Study Start-Up, Clinical Study Assistants, CRAs, and Country Operations Management • Act as the main contact with study sites and monitor study conduct for proper delivery and compliance • Select, initiate, monitor, and close assigned sites in compliance with Alexion procedures, ICH-GCP, and local regulations • Perform selection, initiation, interim monitoring, and closeout visits, remotely and onsite • Conduct remote data checks according to study-specific Clinical Monitoring Plans • Drive site performance and resolve or escalate study-related issues • Train, support, and advise investigators and site staff, including on RBQM principles • Develop site recruitment plans and manage/support enrollment milestones • Monitor study KPIs, including action-item aging, SDV, data entry, query aging, and monitoring-visit report metrics • Prepare and finalize monitoring visit reports in CTMS and provide timely feedback and follow-up letters to Principal Investigators • Collect and upload essential documents to the eTMF and support regular eTMF quality-control checks • Support study start-up and regulatory maintenance, including document preparation, review, tracking, and submissions to EC/IRB and Regulatory Authorities where required • Contribute to investigator nomination, selection, and feasibility activities • Collaborate with Medical Affairs, MAP, and other internal stakeholders • Escalate systematic or serious quality issues, data privacy breaches, and ICH-GCP compliance issues • Prepare for and collaborate on audits and regulatory inspections

🎯 Requirements

• Minimum of 4 years of CRA monitoring experience • Bachelor’s degree in a related discipline, preferably in life science, or equivalent qualification • Excellent knowledge of international guidelines ICH-GCP • Basic knowledge of GMP/GDP • Excellent knowledge of relevant local regulations • Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas • Good understanding of the drug development process • Excellent understanding of Clinical Study Management, including monitoring, study drug handling and data management • Excellent attention to detail • Excellent written and verbal communication skills • Excellent collaboration and interpersonal skills • Good negotiation skills • Flexibility in schedule and willingness to travel; required travel may be as high as 70% during busy periods • Valid driving license • Ability to work with remote collaborators and in a matrix reporting structure • Ability to manage change positively • Ability to identify more efficient and effective methods/processes for delivering quality clinical trials with reduced budget and time • Ability to prioritize and manage multiple tasks with conflicting deadlines • Proactivity and assertiveness when communicating with internal stakeholders and sites • Ability to understand technology’s impact on projects and use/develop computer skills in an e-enabled environment • Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities • Experience in all study phases and rare medical conditions preferred

🏖️ Benefits

• Inclusive environment with equal employment opportunities for all applicants and employees • Disability and special-needs accommodation available through the application form