Clinical Research Associate (WA)

About the role

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.

Key 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 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, and 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

• 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 and identify new potential Investigators and/or sites through ongoing collaborations

• 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

About you

• Bachelor's degree required, preferably within Life Sciences or equivalent

• Valid driver's license (as locally required)

• Strong communication and relationship-building skills

• Strong organizational and time management capabilities

• Ability to work independently while managing multiple priorities

• 2+ years of clinical research experience. We welcome applications from candidates with experience gained within clinical trial sites.

• Knowledge and understanding of clinical research processes, regulations and methodology

• Working knowledge of ICH-GCP Guidelines and applicable local laws and regulations that govern clinical trials

• Analytical thinking and critical thinking skills with capability of using technology to analyze diverse and complex data sets, identify issues, trends, and outliers

• Proficient in Microsoft Office Suite, Clinical Trial Management Systems (CTMS), Electronic Data Capture Systems (eDC), Electronic Trial Master File (eTMF), and RBM tools and platforms (e.g., Veeva, Medidata, CluePoints)