Clinical Research Associate, Cardiovascular – Bilingual English/Spanish

🔥 18 hours ago

🏖️ New Jersey – Remote

🏖️ New Jersey – 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 protocols and sites in the country • Ensure study conduct complies with ICH/GCP, country regulations, company policies and procedures, quality standards, and adverse event reporting requirements • Act as primary site contact and site manager throughout all phases of clinical research studies • Develop and expand the clinical research territory by finding and developing new sites • Participate in internal meetings and workstreams as a subject matter expert for monitoring processes and systems • Develop strong site relationships and ensure continuity throughout trial phases • Perform clinical study site management and monitoring in compliance with ICH-GCP, sponsor SOPs, local laws and regulations, protocol, site monitoring plan, and related documents • Gain in-depth understanding of study protocols and related procedures • Coordinate and manage tasks with sponsor roles to achieve site readiness • Participate in site selection and validation activities • Perform remote and on-site monitoring and oversight to ensure complete, accurate, and unbiased site data and protection of subjects' rights, safety, and well-being • Conduct validation, initiation, monitoring, and close-out visits; prepare timely, clear, comprehensive, and 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, regulatory 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 • Manage and maintain information and documentation in CTMS, eTMF, and other systems • Contribute to CRA team knowledge 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 help develop their clinical research capabilities

🎯 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 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 • Good understanding and working knowledge of clinical research, clinical trial phases, current GCP/ICH, and country clinical research law and guidelines • Good understanding of global, 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 monitoring skills 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 and work in a solution-oriented manner • Root cause analysis and preventive/corrective action implementation • 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 • Customer focus and high quality/compliance mindset • Positive, growth mindset and ability to work independently and be self-driven • Current driver's license preferred • Ability to travel domestically and internationally approximately 65%-75% of working time; expected travel approximately 2-3 days/week • US and Puerto Rico residency required

🏖️ Benefits

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