Clinical Research Associate – Immunology

🕒 July 9

🌵 Arizona, California, +6 more states – Remote

🌵 Arizona – Remote 🏄 California – Remote ⛰️ Colorado – Remote 🐊 Florida – Remote 🌽 Illinois – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote 🤠 Texas – 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.

👻 Ghost score 33%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 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 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 • Gain an in-depth understanding of study protocols and related procedures • Coordinate 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; 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 regarding protocol conduct, recruitment, retention, deviations, regulatory 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, IRBs/IECs, and regulatory authorities • Manage information and documentation in CTMS, eTMF, and other systems within timelines • 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 new sites and help develop their clinical research capabilities • Travel domestically and internationally approximately 65%-75% of working time

🎯 Requirements

• Candidate must reside in Texas, Illinois, Arizona, Florida, California, New York, or Colorado • Associate's degree, certificate or equivalent in a scientific / healthcare discipline and 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 and at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO • Ability to travel domestically and internationally approximately 65%-75% of working time; expected travel approximately 2-3 days/week • Current driver's license required • 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 • 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 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 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 focus and high quality/compliance mindset • Professional demeanor and communication consistent with organizational policies and practices • No visa sponsorship

🏖️ Benefits

• Annual bonus • 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