Clinical Research Associate, Oncology

🕒 August 4

🏄 California, Illinois, +4 more states – Remote

🏄 California – Remote 🌽 Illinois – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote 🏰 Missouri – 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 13%

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 oncology 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 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 to ensure complete, accurate, unbiased data and protection of subjects' rights, safety, and well-being • Conduct validation, initiation, monitoring, and close-out visits and prepare 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, 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 and maintain information and documentation in CTMS, eTMF, and other systems • Contribute to CRA team knowledge as process SME, buddy/mentor, and best-practice contributor • Support or lead audit and inspection activities • Perform co-monitoring visits where appropriate • Identify potential new sites and develop their clinical research capabilities • Travel domestically and internationally approximately 65%-75% of working time

🎯 Requirements

• Candidate must reside in New York, New Jersey, Texas, Chicago, Southern California, or Missouri • 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 • 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 laws and guidelines • Knowledge of global and 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 monitoring skills 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 perform root cause analysis • Ability to implement preventive and corrective actions • 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 • High accountability and urgency • Customer-focused, quality- and compliance-minded, positive, growth-oriented, self-driven, and professional • Ability to travel domestically and internationally approximately 65%-75% of working time, approximately 2-3 days per week • Current driver's license required • U.S. and Puerto Rico residents only • Visa sponsorship is not available

🏖️ 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 required