Senior Clinical Research Associate – Cardiovascular, Bilingual English/Spanish

🔥 0 minutes ago

🌐 United States, Puerto Rico – Remote

🇺🇸 United States – Remote 🇵🇷 Puerto Rico – Remote

🐊 Florida, New Jersey – Remote

🐊 Florida – Remote 🏖️ New Jersey – Remote

💵 $129k - $203.1k / year

⏰ Full Time

🟠 Senior

🧪 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 trial 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 remote and on-site monitoring and oversight activities • Conduct validation, initiation, monitoring, and close-out visits • Ensure data are complete, accurate, and unbiased and protect subjects’ rights, safety, and well-being • 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 • Collaborate with internal clinical operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters teams, vendors, IRBs/IECs, and regulatory authorities • Manage documentation and information in CTMS, eTMF, and other systems • Act as a process SME, share best practices, recommend improvements, and provide training • Support or lead audit and inspection activities • Identify and develop potential new clinical research sites • Mentor junior CRAs and perform co-monitoring visits • Perform quality control visits when delegated and appropriately trained

🎯 Requirements

• Fluent Spanish speaking skills required • Fluent in local languages and English, verbal and written • Associate’s degree, certificate or equivalent in a scientific / healthcare discipline with at least 7 years of relevant healthcare experience, including at least 4 years of direct site management (monitoring) experience in bio / pharma / CRO; or Bachelor’s degree or above with at least 4 years of direct site management experience in a bio / pharma / CRO • Excellent understanding of clinical research, clinical trial phases, current GCP/ICH, and country clinical research laws and guidelines • Excellent understanding of global, country/regional clinical research guidelines • Demonstrated ability to mentor/lead • Hands-on knowledge of Good Documentation Practices • Proven site management skills, including independent management of site performance and patient recruitment • Demonstrated monitoring skills with independent professional judgment • Good IT skills, including MS Office and clinical IT applications • Ability to understand and analyze data/metrics and act appropriately in a virtual environment • Experience conducting site motivational visits to boost site enrollment • Ability to manage complex issues and perform root cause analysis and corrective/preventive action • Effective time management, organizational, interpersonal, conflict management, problem-solving, and multitasking skills • Ability to work independently across multiple protocols, sites, and therapy areas • Ability to work effectively in a matrix multicultural environment • Current driver’s license required • Ability to travel domestically and internationally approximately 65%-75% of working time

🏖️ Benefits

• Annual bonus and long-term incentive, if applicable • Medical, dental, vision healthcare and other insurance benefits for employee and family • Retirement benefits, including 401(k) • Paid holidays • Vacation • Compassionate and sick days • Remote work arrangement • No relocation required