Clinical Research Associate- San Antonio / South-Central Texas Region

We need to output HTML fragment with sections: About the role? The posting includes a purpose-driven culture paragraph at start. That could be "About the role" or maybe "About the company". The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Do NOT repeat the job title as a heading. So we need sections based on content present. We have: - Intro paragraph about Bristol Myers Squibb purpose-driven culture. That could be "About the role" or maybe "About the company". Since they ask "About the role" as example, we can use that. - Position Summary: description of CRA role. Could be part of About the role or separate "Position Summary". But we can include under About the role. - Key Responsibilities: list of duties. Use

• . - Qualifications & Experience: list of qualifications. Use
  • . - Competencies: list of competencies. Could be under Skills or Requirements. The instruction: use headings like Skills, Requirements, Qualifications. We have Qualifications & Experience separate; Competencies could be Skills. - Travel: mention up to 70% travel. That's not Pay/Schedule/Benefits but could be under Schedule? Travel is not schedule. Could be under "Schedule" maybe not. The instruction: only include Pay/Schedule/Benefits if posting actually states them. Travel is not schedule; we could omit or maybe include under "Schedule"? Better to omit if not explicitly schedule. The posting says "Travel: This position may require up to 70% travel". That's not schedule but could be considered under "Schedule"? I'd omit to avoid creating a section without real content? But we have content. However the instruction says include a section ONLY when posting has real, specific content for it. Travel is specific content. But they gave example headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Travel is not one of those. Could we add a custom heading? The instruction says use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It doesn't forbid other headings, but suggests those examples. Safer to stick to those headings. Travel could be placed under "Schedule"? Not exactly. Could be under "Responsibilities"? Not really. Might be better to include a "Travel" section with

    Travel

    but that deviates from examples. The instruction: "Use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It implies those are typical but not exclusive? It says e.g., meaning for example. So we could add Travel heading. However they also say "Prefer a few substantive sections over many thin ones." So maybe combine travel into Responsibilities or Qualifications? Travel is a condition, not a responsibility. Could be under "Requirements"? Not ideal. Maybe we can include a "Schedule" section and put travel there? But schedule usually refers to work schedule (full-time, part-time, shift). Travel is not schedule. Might be okay to add a "Travel" section. Also we have Compensation Overview with pay range. That's Pay section. Benefits section present. Thus sections: About the role (intro + position summary), Responsibilities, Qualifications, Skills (competencies), Pay, Benefits, Travel (optional). Also maybe Requirements? Qualifications & Experience already covers requirements. Could rename Qualifications & Experience to Requirements? But they said Qualifications as heading. We'll use Qualifications. We need to preserve all substantive information, not invent or summarize away detail. Must not repeat job title as heading. Must not put Job ID/requisition numbers as headings. We can drop metadata. We must remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. So we need to strip out the supporting sections: "How We Work", "Supporting People With Disabilities", "Candidate Rights", "Data Protection", etc. Also the line "We hire for skills and capabilities..." maybe keep? That's more about encouraging apply; could be considered boilerplate? It's not legal but it's a generic encouraging statement. Might be considered part of posting but not substantive? It's not a duty/requirement. Could be omitted as it's not essential. Safer to omit. Also we need to keep the compensation overview and benefits details. We must output only HTML fragment, no /, no markdown fences. Let's craft:

    About the role

    At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

    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.

    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
    • 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

    • 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

    Skills

    • 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)

    Pay

    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