Clinical Research Associate – Cardiovascular, Vaccine, Infectious Disease

Job not on LinkedIn

🕒 August 7

🏄 California, Colorado, +5 more states – Remote

🏄 California – Remote ⛰️ Colorado – Remote 🐊 Florida – Remote 🌽 Illinois – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote 🤠 Texas – Remote

💵 $96.2k - $151.4k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• Ensure performance and compliance for assigned clinical research protocols and sites • Act as primary site contact and site manager throughout all phases of clinical research studies • Develop and maintain strong site relationships • Perform clinical study site management and monitoring in compliance with ICH-GCP, SOPs, laws, regulations, protocols, and monitoring plans • Coordinate tasks with sponsor roles to achieve site readiness • Participate in site selection and validation activities • Perform remote and on-site monitoring and oversight • Conduct validation, initiation, monitoring, and close-out visits • Prepare accurate visit and non-visit contact reports • Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out • Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, deviations, documentation, audits, inspections, and site performance • Identify, assess, resolve, and escalate site performance, quality, and compliance issues • Partner with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters functions, vendors, IRBs/IECs, and regulatory authorities • Maintain information and documentation in CTMS, eTMF, and other systems • Contribute as a process SME, buddy/mentor, and best-practice sharer • Support or lead audit and inspection activities • Perform co-monitoring visits when appropriate • Identify potential new sites and develop their clinical research capabilities • Travel domestically and internationally approximately 65%-75% of working time, approximately 2-3 days per week

🎯 Requirements

• Must reside in Illinois, Colorado, South Florida, New York, California, Houston, or Dallas • Associate’s degree, certificate, or equivalent in a scientific/healthcare discipline plus at least 5 years of relevant healthcare experience, including at least 2 years of direct site management/monitoring experience in a bio/pharma/CRO; or bachelor’s degree or above plus at least 2 years of direct site management/monitoring experience in a bio/pharma/CRO • Current driver’s license required • Approximately 65%-75% domestic and international travel; expected travel of approximately 2-3 days per week • Fluent in local languages and English, verbal and written • Working knowledge of clinical research, clinical trial phases, current GCP/ICH, and country clinical research laws and guidelines • Knowledge of global and country/regional clinical research guidelines • Hands-on knowledge of Good Documentation Practices • Proven site management skills, including site performance and patient recruitment • Demonstrated high level of monitoring skill with independent professional judgment • Good IT skills, including MS Office and clinical IT applications on computers, tablets, and mobile devices • Ability to understand and analyze data/metrics and act appropriately • Ability to manage complex issues, perform root cause analysis, and implement preventive and corrective action • Effective time management, organizational, interpersonal, conflict management, and problem-solving skills • Ability to work independently across multiple protocols, sites, and therapy areas • Ability to prioritize and handle multiple tasks in a changing environment • Ability to work effectively in a matrix multicultural environment and establish culturally sensitive working relationships • Customer-focused, quality-focused, and compliance-focused mindset • Positive, growth-oriented, self-driven, and professional demeanor • Required knowledge of adverse event reporting systems, clinical research methods, clinical site management, clinical study management, clinical trial planning and monitoring, data analysis/reporting, early clinical development, policy development, preventive action, protocol adherence, regulatory compliance, and site management

🏖️ Benefits

• Annual bonus eligibility • Long-term incentive eligibility, if applicable • Medical healthcare benefits • Dental healthcare benefits • Vision healthcare benefits • Other insurance benefits for employee and family • Retirement benefits, including 401(k) • Paid holidays • Vacation • Compassionate days • Sick days • Remote work arrangement