Bristol Myers Squibb
Clinical Research Associate- West Region - USA
Bristol Myers Squibb, Minneapolis, Minnesota, United States, 55400
Overview
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 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 as available for clinical trial site personnel and ensure 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. 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) 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: Microsoft Suite, CTMS, eDC, eTMF, RBM tools and platforms (e.g., Veeva, Medidata, CluePoints) Compensation & Benefits
The starting compensation range for this role is $104,680 - $126,845 (Field - United States - US). Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Benefits include Medical, dental, vision, 401(k), life insurance, disability, paid holidays, vacation, volunteer days, leave programs and other perks as described on the careers site. Equal Opportunity & Accessibility
BMS is committed to an inclusive workforce. Applicants can request reasonable accommodations prior to accepting a job offer. For accommodation inquiries, contact adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for the full Equal Employment Opportunity statement.
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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 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 as available for clinical trial site personnel and ensure 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. 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) 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: Microsoft Suite, CTMS, eDC, eTMF, RBM tools and platforms (e.g., Veeva, Medidata, CluePoints) Compensation & Benefits
The starting compensation range for this role is $104,680 - $126,845 (Field - United States - US). Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Benefits include Medical, dental, vision, 401(k), life insurance, disability, paid holidays, vacation, volunteer days, leave programs and other perks as described on the careers site. Equal Opportunity & Accessibility
BMS is committed to an inclusive workforce. Applicants can request reasonable accommodations prior to accepting a job offer. For accommodation inquiries, contact adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for the full Equal Employment Opportunity statement.
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