Clinical Research Associate – Immunology

🔥 2 minutes 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.

👻 Ghost score 0%

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.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 • 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 strong site relationships and ensure continuity throughout trial phases • Perform clinical study site management and monitoring in compliance with applicable requirements • Gain 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 activities • Conduct validation, initiation, monitoring, and close-out visits • Prepare 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, 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 • Maintain information and documentation in CTMS, eTMF, and other systems • Contribute to CRA team knowledge as 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

🎯 Requirements

• 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 • Experience in Immunology preferred • 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 • Understanding of clinical research, clinical trial phases, GCP/ICH, and country clinical research laws and guidelines • Understanding of global, country/regional clinical research guidelines • Knowledge of Good Documentation Practices • Proven site management skills, including site performance and patient recruitment • High-level monitoring skills with independent professional judgment • Good IT skills, including MS Office and clinical IT applications • Ability to understand and analyze data/metrics • Ability to manage complex issues and perform root cause analysis • Effective time management, organizational, interpersonal, conflict management, and problem-solving skills • Ability to work independently across multiple protocols, sites, and therapy areas • Ability to work effectively in a matrix multicultural environment • Commitment to customer focus and quality/compliance • Adverse Event Reporting System • Clinical Research • Clinical Research Methods • Clinical Site Management • Clinical Study Management • Clinical Trial Planning • Clinical Trials Monitoring • Cultural Awareness • Customer Centricity • Document Management • Good Clinical Data Management Practice (GCDMP) • Good Clinical Practice (GCP) • Matrix Management • On Site Management • Pharmaceutics • Protocol Adherence • Protocol Review • Regulatory Affairs Management • Regulatory Compliance • Regulatory Inspections • Relationship Building • Remote Monitoring • Site Management • Study Design

🏖️ 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