[Hiring] Clinical Research Associate @Bristol Myers Squibb

Role Description

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.

• 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.
• 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.
• 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.
• 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.
• Utilize strong analytical skills to evaluate site data and operational metrics.
• 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.
• Involvement in Regulatory Compliance audit/inspection process, as needed.
• 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 for clinical trial site personnel.
• 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.

Requirements

• 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.
• 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.
• Organization and time management skills.
• Ability to build, maintain and strengthen relationships even under pressure and/or in difficult situations.
• Good verbal and written communication skills (both in English and local language).
• Foundational level of disease understanding and awareness.
• Proven ability to work independently with a high degree of autonomy.
• Ability to manage multiple protocols, across multiple therapeutic areas, which may require travel.
• Proficient in navigating and utilizing multiple clinical systems (e.g., CTMS, eTMF, RBQM dashboards).
• Software that must be used independently and without assistance (e.g., Microsoft Suite, CTMS, eDC, eTMF, RBM tools and platforms).

Benefits

• Comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• Flexible Time Off (FTO) for U.S.-based exempt employees, along with 11 paid company holidays each year.
• 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays for non-exempt employees.
• Access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, and leaves of absence for various needs.
• Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees.