Jobs · Analyst

Clinical Research Associate - Ohio Region

Bristol Myers Squibb · Lawrence, NJ · 1 mo ago
RemoteRemoteAnalyst$105k–$127k/yrFull-time
We need to output HTML fragment with sections: Use

for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We must not repeat job title as heading. We must include sections only when posting has real specific content. We must preserve all substantive info, not invent or summarize away detail. Remove boilerplate etc. We need to parse the posting. Key parts: - Intro paragraph about BMS purpose etc. Could be "About the role" or maybe "About the role" is generic; but we can put a

for the introductory prose before sections. The instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use
  • for any list of duties/requirements/benefits, and

    for prose. Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short

    or drop it. We need to include sections only when posting has real specific content. We have content for: - About the role: maybe the introductory paragraph about BMS purpose and the role summary. - Responsibilities: many bullet-like sentences (though not bullet list). We need to turn them into

    • . The posting repeats some lines; we need to preserve all substantive info, but we can deduplicate? The instruction: Preserve ALL substantive information; do NOT invent or summarize away detail. Remove duplicated lines. So we should deduplicate repeated responsibilities. - Qualifications & Experience: list of qualifications. - Competencies: list of competencies (knowledge, skills). Could be under Skills or Requirements? The headings list includes Skills. Could treat Competencies as Skills. - Travel: mention travel up to 70% travel. That could be under Schedule? Or maybe a separate section? The headings list includes Schedule. Travel could be part of Schedule? But we have no explicit schedule besides travel. Could create a Schedule section with travel info. - Compensation Overview: Pay range. So we need a Pay section with the salary range. - Benefits: Benefits section. - How We Work: maybe not needed; but could be omitted as not in headings list. - Supporting People With Disabilities etc: boilerplate; remove. - Candidate Rights etc: remove. - Data Protection etc: remove. - Job ID line: "R1606243 Clinical Research Associate - Ohio Region" - we should fold minor metadata into a short

      or drop it. Probably we can include a

      with Job ID and location. We must not include sections with filler like "commensurate with experience". Not present. We need to output only HTML fragment, no /, no markdown fences. Let's extract content. First, introductory paragraph: "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." Then "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." We could combine into About the role section. Now Responsibilities: Let's list unique responsibilities. From text: - 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 (appears twice, but we keep once) - 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. We need to ensure we didn't miss any. Now 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. Now Competencies (Skills): List: - 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). Note there is duplication: "Microsoft Suite" appears twice; we can deduplicate. Travel: "This position may require up to 70% travel" Pay: "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." We need to output Pay section with the range. Probably just include the range and maybe note that it's for FTE etc. But we should preserve all substantive info; we can include the whole paragraph but maybe condense? The instruction: do NOT invent or summarize away detail. So we should keep the detail, not summarize. However we can keep the paragraph as is; it's not a list, so

      . Benefits: The benefits paragraph is long. We need to preserve all substantive info. We'll put in a

      under Benefits heading. How We Work etc: Not in headings list; we could omit as not required. The instruction: Prefer a few substantive sections over many thin ones. So we can skip How We Work. Supporting People With Disabilities etc: boilerplate; remove. Candidate Rights etc: remove. Data Protection etc: remove. Job ID line: we can put a short

      at top: "Job ID: R1606243 – Location: Ohio Region". Or we could drop it. The instruction: fold minor metadata into a short

      or drop it. We'll include a short

      . Now structure: We'll start with a

      for intro (maybe combine intro and position summary). Then

      About the role

      with

      containing the intro and position summary? Actually About the role could be the intro paragraph plus position summary. We'll put that in a

      . Then

      Responsibilities

      with
      • each responsibility. Then

        Qualifications

        with
        • each qualification. Then

          Skills

          with
          • each competency/skill. Then

            Travel

            ? Not in headings list but we have Schedule heading. Travel could be under Schedule. We'll use

            Schedule

            with

            about travel up to 70%. Then

            Pay

            with

            containing compensation overview. Then

            Benefits

            with

            containing benefits paragraph. Finally maybe a

            for Job ID. We must not repeat job title as heading. Good. Now ensure we don't include any boilerplate like EEO etc. Let's craft. We need to be careful to not include duplicated lines. Let's write responsibilities list items exactly as in text, but ensure no duplication. I'll write them: - Conduct site qualification, initiation, routine monitoring and close-out visits

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