Clinical Research Associate – Cardiovascular

🔥 13 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 a country • Ensure study conduct complies with ICH/GCP, country regulations, company policies, 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 site relationships and ensure continuity throughout all trial phases • Perform clinical study site management and monitoring activities • Coordinate and manage tasks with sponsor roles to achieve Site Ready • Participate in site selection and validation activities • Perform remote and on-site monitoring and oversight activities • Conduct validation, initiation, monitoring and close-out visits and document 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 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 by sharing best practices • Support and/or lead audit and inspection activities • Perform co-monitoring visits • Identify potential sites and help develop their clinical research capabilities

🎯 Requirements

• Associate's degree, certificate or equivalent in a scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field, including at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO; or Bachelor's degree (or above) together with at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO • Fluent in Local Languages and English (verbal and written) • Good understanding and working knowledge of clinical research, phases of clinical trials, 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 skills in site management, including management of 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 computer, tablet and mobile devices • Ability to understand and analyze data/metrics • Ability to perform root cause analysis and implement preventative and corrective action • Effective time management, organizational, interpersonal, conflict management and problem-solving skills • Able to work independently across multiple protocols, sites and therapy areas • Ability to set priorities and handle multiple tasks simultaneously • Ability to work effectively in a matrix multicultural environment • Commitment to customer focus and high quality/compliance standards • Current driver's license preferred

🏖️ Benefits

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