Clinical Research Associate

Bristol Myers Squibb offers a challenging, meaningful, and life-changing work environment where employees transform patients' lives through science. The Clinical Research Associate (CRA) is a primary site-level contact, responsible for overseeing the quality, integrity, and compliance of clinical trial sites according to protocol, SOPs, ICH GCP, and regulatory requirements. This role involves maintaining ethical and scientific integrity, monitoring adherence to guidelines, and fostering relationships with stakeholders to meet study objectives.

Must Have

• Conduct site qualification, initiation, routine monitoring and close-out visits
• Ensure adherence to protocol, BMS SOPs, and ICH GCP
• Verify data within electronic systems and paper records for accuracy
• Monitor site adherence to ICH GCP and local regulations, including ALCOA principles
• Provide training and support to site staff to ensure patient safety
• Cultivate and sustain effective relationships with internal and external partners
• Serve as the organization’s representative for clinical trials at the site level
• Motivate and influence sites to meet study objectives, including enrollment and retention
• Communicate effectively, adapting to different stakeholders' needs
• Prepare and submit timely, accurate, concise, professional, and objective written reports
• Assess potential Investigators and sites for sufficient resources and capabilities
• Demonstrate understanding of targeted, centralized, remote, and risk-based monitoring approaches
• Identify, assess, and prioritize risks at site and study level, supporting mitigation strategies
• Utilize strong analytical skills to evaluate site data and operational metrics
• Perform Unblinded Site Monitor activities to protect study blind (if applicable)
• Accountable for review, reconciliation, and oversight of study drug/IMP
• Involvement in Regulatory Compliance audit/inspection process
• Support start-up and submission activities, including ICF reviews and document collection
• Ensure access to relevant BMS and vendor systems for site personnel
• Support coordination of site activities related to database locks
• Perform timely site closure activities
• Bachelor’s degree, preferably in life sciences or equivalent
• Valid driver’s license (as locally required)
• 2-3 years of relevant clinical research experience, able to work independently
• Proficiency in all aspects of the CRA role
• Experience in the drug discovery/development process
• Knowledge of clinical research processes, regulations, and methodology
• Understanding of clinical landscape, medical settings, and medical records management
• Working knowledge of ICH/GCP Guidelines and applicable local laws
• Analytical thinking/critical thinking skills
• Capable of using technology to analyze diverse and complex data sets
• Organization and time management skills
• Ability to build, maintain, and strengthen relationships
• Good verbal and written communication skills (English and local language)
• Foundational disease understanding and awareness
• Proven ability to work independently with high autonomy
• Ability to manage multiple protocols across therapeutic areas
• Proficient in Microsoft Suite, CTMS, eDC, eTMF, RBM tools and platforms

Good to Have

• Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator

Perks & Benefits

• Benefits and Wellbeing: Global platform and benefits for physical, mental, financial and social wellbeing
• Recognition: Global platform to reward your achievements
• Time Off: Generous time off to rest and recharge
• Health Benefits: Best-in-class benefits
• 8 People & Business Resource Groups

Life at BMS

Working with Us

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position summary

The Clinical Research Associate (CRA) is a primary point of contact at the site level for both internal and external stakeholders, responsible for overseeing the quality, integrity and compliance of clinical trial sites in accordance with the protocol, Standard Operating Procedures (SOPs), International Council for Harmonization (ICH) Guideline for Good Clinical Practice (GCP), and applicable regulatory requirements.

Key Responsibilities

• Conduct site qualification, initiation, routine monitoring and close-out visits across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP
• Maintain the ethical and scientific integrity of clinical trials by verifying data within electronic systems and paper records (as applicable) to ensure the accessibility, completeness and accuracy of data submitted by study sites
• Conduct site qualification, initiation, routine monitoring and close-out visits across all trial phases in accordance with the Site Monitoring Plan, ensuring adherence to protocol, BMS Standard Operating Procedures (SOPs) and ICH GCP
• Monitor site adherence to ICH GCP and local regulations, including compliance with the principles of ALCOA to maintain data integrity and reliability. Where required, provide training and support to site staff to uphold these standards and ensure patient safety. Participate in sponsor and/or Health Authority audits and inspections as applicable.
• Cultivate and sustain effective relationships with internal cross-functional teams and external partners, including vendors, clinical sites, and key stakeholders.
• Serve as the organization’s representative for clinical trials at the site level.
• Motivate and influence sites to meet study objectives, including enrollment and retention goals.
• Communicate effectively, adapting to meet the needs of different stakeholders, utilizing the most appropriate communication style and method
• Prepare and submit written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
• Assess potential Investigators and their sites to ensure sufficient resources and capabilities to conduct clinical trials. May identify new potential Investigators and/or sites through ongoing collaborations with internal and external stakeholders during the site feasibility and selection process.
• Demonstrate understanding and proficiency working with targeted, centralized, remote and risk-based monitoring approaches
• Identify, assess, and prioritize risks at the site and study level and support sites in mitigating issues, including implementing mitigation strategies based on risk indicators
• Utilize strong analytical skills to evaluate site data and operational metrics, including ability to adjust monitoring strategies based on data trends and site performance
• Where applicable, perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor
• Accountable for the review, reconciliation, and oversight of study drug/IMP. May support study drug/IMP label translation needs as applicable.
• Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions.
• In specific instances, may support start-up and submission related activities, including ICF reviews and collection of documents to/from site.
• Support provision of access to relevant BMS and vendor systems is available for clinical trial site personnel and ensures internal BMS systems are kept up to date for site monitoring activities.
• Support coordination of site activities related to database locks to ensure timelines are met as required locally.
• Perform timely site closure activities when all required protocol visits and follow-up are completed.

Qualifications & Experience

Degree/Certification/Licensure:

• Bachelor’s degree required, preferably within life sciences or equivalent
• Valid driver’s license (as locally required)

Experience:

• Clinical Research Associate: 2-3 years of relevant clinical research experience, able to work independently, demonstrates proficiency in all aspects of the role
• Extensive experience and demonstrated strong performance in all aspects of the role.
• Relevant prior Pharma/Biotech Sponsor employment or experience as a clinical study coordinator preferred
• Experience in the drug discovery/development process.

Competencies

• Knowledge and understanding of clinical research processes, regulations and methodology
• Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
• Working knowledge of ICH/GCP Guidelines and applicable local laws and regulations that govern clinical trials, with the ability to apply regulatory requirements to ensure compliance in clinical research activities.
• Analytical thinking/critical thinking skills.
• Capable of using technology to analyze diverse and complex data sets, identify issues, trends, and outliers to develop effective solutions (Demonstrate adaptability and a growth mindset by quickly learning and applying new technologies, embracing evolving methodologies, and remaining open to innovative ways of working in a dynamic environment
• Organization and time management skills
• Ability to build, maintain and strengthen relationships even under pressure and/ or in difficult situations with internal and external stakeholders
• Good verbal and written communication skills (both in English and local language)
• Have a foundational level of disease understanding and awareness (how the protocol fits in current landscape, standard of care, etc.)
• Proven ability to work independently with a high degree of autonomy, proactively managing tasks and seeking opportunities for continuous learning
• Ability to manage multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory
• Proficient in navigating and utilizing multiple clinical systems (e.g., CTMS, eTMF, RBQM dashboards) to identify and resolve issues, support site performance, and ensure data integrity

Software that must be used independently and without assistance (e.g., Microsoft Suite)

• Microsoft Suite
• Clinical Trial Management Systems (CTMS)
• Electronic Data Capture Systems (eDC)
• Electronic Trial Master File (eTMF)
• RBM tools and platforms (e.g., Veeva, Medidata, CluePoints).

#LI-Remote

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at http://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.