Clinical Research Associate – Immunology

🔥 0 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 in a country • Ensure study conduct compliance 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 activities according to applicable standards, regulations, protocols and monitoring plans • Gain an in-depth understanding of study protocols and related procedures • 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; prepare timely 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, regulatory 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 • Manage and maintain information and documentation in CTMS, eTMF and other systems • Contribute to CRA team knowledge as process SME, buddy/mentor and by sharing best practices • 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 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 • Experience in Immunology preferred • Ability to travel domestically and internationally approximately 65% - 75% of working time; expected travelling 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, 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 and act appropriately • Ability to manage complex issues and work in a solution-oriented manner • Root cause analysis and preventative/corrective action experience • 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 simultaneously • Ability to work effectively in a matrix multicultural environment and maintain culturally sensitive working relationships • Customer focus and high quality/compliance mindset • Positive, growth mindset and ability to be self-driven • Professional demeanor and communication consistent with organizational policies and practices • US and Puerto Rico residents only • Visa sponsorship is not available

🏖️ Benefits

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