Clinical Research Associate – Oncology

🔥 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.

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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

• Ensure performance and compliance for assigned protocols and sites in the country • Ensure study conduct compliance 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 all trial phases • Perform clinical study site management and monitoring in compliance with ICH-GCP, SOPs, local laws, regulations, protocols, and monitoring plans • 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; document 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 teams, vendors, IRBs/IECs, and regulatory authorities • Manage and maintain information and documentation in CTMS, eTMF, and other systems • Contribute as a process SME, buddy/mentor, and best-practice contributor • Support and/or lead audit and inspection activities • Perform co-monitoring visits • Identify potential new sites and help develop their clinical research capabilities

🎯 Requirements

• Associate's degree, certificate or equivalent in a scientific / healthcare discipline and at least 5 years of relevant healthcare-field 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 • Fluent in local languages and English, verbal and written • Understanding and working knowledge of clinical research, clinical trial phases, current GCP/ICH, and country clinical research law and guidelines • Knowledge 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 monitoring skills 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 • Ability to manage complex issues and perform root cause analysis • 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 • Commitment to customer focus and quality/compliance • Approximately 65%-75% domestic and international travel; expected travel approximately 2-3 days/week • Current driver's license preferred • No visa sponsorship

🏖️ 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 and sick days • Remote work arrangement