Clinical Research Associate

🔥 1 minute ago

🏈 Ohio – Remote

🏈 Ohio – 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 • Conduct site qualification, initiation, routine monitoring, and close-out visits across all trial phases • Ensure adherence to protocols, BMS SOPs, ICH GCP, and applicable regulations • Verify clinical-trial data in electronic systems and paper records for accessibility, completeness, and accuracy • Monitor site compliance, provide training and support, and participate in audits and inspections • Build relationships with cross-functional teams, vendors, clinical sites, and key stakeholders • Motivate and influence sites to meet enrollment and retention objectives • Prepare timely, accurate, concise, professional monitoring and administrative reports • Assess Investigators and sites for resources and capabilities and identify potential new sites • Apply targeted, centralized, remote, and risk-based monitoring approaches • Identify and prioritize site and study risks and support mitigation strategies • Analyze site data and operational metrics and adjust monitoring strategies based on trends and performance • Perform Unblinded Site Monitor activities when applicable to protect study blinding • Review, reconcile, and oversee study drug/IMP and support label translation needs when applicable • Support regulatory compliance audits, inspections, and corrective and preventive actions • Support study start-up, submissions, ICF reviews, and site document collection when applicable • Support access to BMS and vendor systems and maintain internal systems for monitoring activities • Coordinate site activities related to database locks • Perform timely site closure activities after required visits and follow-up are completed

🎯 Requirements

• Bachelor’s degree required, preferably within life sciences or equivalent • 2–3 years of relevant clinical research experience • Valid driver’s license, as locally required • Ability to work independently and proficiency in all aspects of the role • 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, growth mindset, and ability to learn and apply new technologies • 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 clinical systems including CTMS, eTMF, and RBQM dashboards • Proficiency with Microsoft Suite • Proficiency with Electronic Data Capture Systems (eDC) • Experience with RBM tools and platforms such as Veeva, Medidata, or CluePoints • Ability to travel up to 70% • AI experience or initial knowledge strongly preferred • Relevant prior Pharma/Biotech Sponsor employment or clinical study coordinator experience preferred

🏖️ Benefits

• Additional discretionary incentive cash and stock opportunities • Wellbeing support • Retirement and financial protection benefits • Medical, dental, vision, life and disability insurance offerings • Flexible Time Off (FTO) without a set accrual limit for eligible 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, depending on eligibility • Up to two paid volunteer days per year • Summer hours flexibility • Medical, personal, parental, caregiver, bereavement, and military leaves of absence • Annual Global Shutdown between Christmas Day and New Year's Day • Workplace accommodations/adjustments and ongoing support for people with disabilities