Position SummaryThe 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: - 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, able to work independently, demonstrates proficiency 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
- Demonstrated adaptability and a growth mindset by quickly learning and applying new technologies (AI experience or initial knowledge strongly preferred), 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).
Travel: This position may require up to 70% travel
#LI-remote
We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.
Compensation Overview:Field - United States - US: $104,680 - $126,845
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including 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. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We WorkWhere you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
