Clinical Research Associate

🔥 0 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

💵 $104.7k - $126.8k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Bristol Myers Squibb

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1887

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Bristol Myers Squibb is a global biopharmaceutical company that is dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Their areas of focus include cardiovascular health, cell therapy, immunology, and oncology. With a commitment to transforming patient outcomes through pioneering science, Bristol Myers Squibb partners with a worldwide network of researchers, healthcare providers, and other stakeholders. They aim to lead in innovation for patients while fostering diversity and inclusion within their workforce.

📋 Description

• Serve as the primary site-level contact for internal and external clinical-trial stakeholders • Oversee the quality, integrity, and compliance of clinical trial sites • Conduct site qualification, initiation, routine monitoring, and close-out visits across all trial phases • Verify clinical-trial data in electronic systems and paper records for accessibility, completeness, and accuracy • Monitor adherence to ICH GCP and local regulations, provide site training and support, and participate in audits and inspections • Build relationships with cross-functional teams, vendors, clinical sites, and key stakeholders • Motivate sites to meet enrollment and retention goals • Prepare and submit monitoring and administrative reports • Assess investigators and sites for resources and capabilities; identify potential investigators and sites • Apply targeted, centralized, remote, and risk-based monitoring approaches • Identify, prioritize, and mitigate site- and study-level risks • Analyze site data and operational metrics and adjust monitoring strategies • Perform unblinded site-monitor activities when applicable • Review, reconcile, and oversee study drug/IMP • Support regulatory compliance audits, inspections, corrective and preventive actions, and start-up/submission activities • Support access to BMS and vendor systems and maintain internal systems for site monitoring • Coordinate site activities related to database locks • Perform timely site closure activities

🎯 Requirements

• Bachelor’s degree required, preferably within life sciences or equivalent • Valid driver’s license as locally required • 2–3 years of relevant clinical research experience • Relevant prior Pharma/Biotech Sponsor employment or clinical study coordinator experience preferred • Experience in the drug discovery/development process • Knowledge of clinical research processes, regulations, and methodology • Practical knowledge of medical settings and medical records management • Working knowledge of ICH/GCP Guidelines and applicable local laws and regulations • Analytical and critical thinking skills • Ability to analyze complex data sets and identify issues, trends, and outliers • Adaptability and ability to learn and apply new technologies; AI experience or initial knowledge strongly preferred • Organization and time management skills • Ability to build and maintain relationships with internal and external stakeholders • Good verbal and written communication skills in English and the local language • Foundational disease understanding and awareness • Ability to work independently with a high degree of autonomy • Ability to manage multiple protocols across multiple therapeutic areas • Proficiency with CTMS, eTMF, RBQM dashboards, Microsoft Suite, Electronic Data Capture Systems, and RBM tools/platforms such as Veeva, Medidata, and CluePoints • Ability to travel up to 70%

🏖️ Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life and disability insurance • Flexible Time Off (FTO) for U.S.-based exempt employees • 11 paid company holidays each year • 160 hours of paid vacation annually for eligible new hires • 3 optional holidays for eligible non-exempt, RayzeBio, and Puerto Rico employees • Paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs, depending on eligibility • Annual Global Shutdown between Christmas Day and New Year's Day • Reasonable workplace accommodations/adjustments and ongoing support • Additional discretionary incentive cash and stock opportunities may be available