Senior Clinical Research Associate – Early-Stage Development

🔥 0 minutes ago

🏖️ New Jersey – 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

• Accountable for 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 monitoring-process subject matter expert • Develop strong site relationships and ensure continuity throughout trial phases • Perform clinical study site management and monitoring in compliance with applicable standards, laws, regulations, protocols, and monitoring plans • Coordinate tasks with sponsor roles to achieve Site Ready • Participate in site selection and validation activities • Perform remote and on-site monitoring and oversight • Conduct validation, initiation, monitoring, and close-out visits • Record 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 internal operations, finance, regulatory affairs, pharmacovigilance, legal, regional, and headquarters teams, plus vendors, IRB/IECs, and regulatory authorities • Manage information and documentation in CTMS, eTMF, and other systems • Act as process SME, share best practices, recommend improvements, and provide training • Support or lead audit and inspection activities • Identify potential new sites and develop their clinical research capabilities • Mentor and buddy junior CRAs and perform co-monitoring visits • Perform quality control visits when delegated and appropriately trained

🎯 Requirements

• ESD experience required • Associate’s degree, certificate, or equivalent in a scientific / healthcare discipline plus 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 plus at least 4 years of direct site management experience in a bio / pharma / CRO • Ability to travel domestically and internationally approximately 65%-75% of working time; expected travel of approximately 2-3 days/week • Current driver’s license required • Fluent in local languages and English, verbal and written • Excellent understanding of clinical research, clinical trial phases, current GCP/ICH, and country clinical research law and guidelines • Understanding of global, country/regional clinical research guidelines and ability to work within them • Demonstrated ability to mentor/lead • Working knowledge of Good Documentation Practices • Proven site management skills, including independent management of site performance and patient recruitment • Demonstrated 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 in a virtual environment • Experience conducting site motivational visits to boost site enrollment • Ability to manage complex issues and work in a solution-oriented manner • Root cause analysis and preventative/corrective action implementation • Ability to mentor junior CRAs and perform co-monitoring visits • Effective time management, organizational, interpersonal, conflict management, and problem-solving skills • Ability to work independently across multiple protocols, sites, and therapy areas • Ability to set priorities and handle multiple tasks in a changing environment • Ability to work effectively in a matrix multicultural environment and maintain culturally sensitive working relationships • Customer-focused, high-quality, and compliance-oriented mindset • Current driving license required • No visa sponsorship

🏖️ Benefits

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