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Position Summary:
Senior 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.
Duties/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
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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.
May support Ethics Committee submissions, ICF reviews, 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.
Functions independently and acts autonomously.
May serve as Lead CRA for a local study as directed by RCO Country/Cluster leadership, responsible for operational outcomes and deliverables.
May engage with Clinical Trial Manager and/or line management to assist in the resolution of more complex issues and widespread issues (i.e. country level issues).
May serve as a role subject matter expert for continuous improvement initiatives and process enhancements as needed
Serve as a subject matter expert in risk-based management methodologies and tools
Serve as a subject matter expert in root cause analysis and CAPA (Corrective and Preventive Actions) processes
Serve as a key resource for colleagues, by providing guidance, leading training and mentoring to other team members through a mentoring process using informal and/or formal presentations
May be delegated by line management to conduct monitoring onboarding and ongoing competency assessments
Qualifications:
Bachelor’s degree required, preferably within life sciences or equivalent
Experience:
Atleast 5 years of monitoring experience. Demonstrates leadership attributes and capability to take on mentor/coach role. Extensive experience and demonstrated strong performance in all aspects of the role.
Relevant prior Pharma/Biotech Sponsor employment or experience
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:
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).
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/
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