Clinical Research Associate – Neurology

🔥 0 minutes ago

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $96.2k - $151.4k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

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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 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 monitoring-process Subject Matter Expert • Develop strong site relationships and ensure continuity throughout all 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 associated documents • Coordinate tasks with sponsor roles to achieve Site Ready • Provide input on site selection and validation activities • Perform remote and on-site monitoring and oversight activities • Conduct validation, initiation, monitoring, and close-out visits; document visit and non-visit contact reports accurately and promptly • Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out • Communicate with investigators and site staff about protocol conduct, recruitment, retention, deviations, documentation, audits/inspections, and site performance • Identify, assess, resolve, and escalate site performance, quality, and compliance problems • Partner with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters functions, vendors, IRB/IECs, and regulatory authorities • Manage 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 where appropriate • Identify potential sites and help develop their clinical research capabilities according to country strategy

🎯 Requirements

• Associate's degree, certificate or equivalent in a scientific / healthcare discipline plus at least 5 years of relevant healthcare-field 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 • Experience in Neurology preferred • Fluent in local languages and English, verbal and written • 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 management • 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 manage complex issues and work in a solution-oriented manner • Root cause analysis and preventive/corrective action skills • Effective time management, organizational, interpersonal, conflict management, problem-solving, and prioritization skills • Ability to work independently across multiple protocols, sites, and therapy areas • Ability to work effectively in a matrix multicultural environment and maintain culturally sensitive working relationships • Customer focus and high quality/compliance mindset • Ability to travel domestically and internationally approximately 65%-75% of working time; expected travel approximately 2-3 days/week • Current driver's license preferred

🏖️ 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