Senior Clinical Research Associate IKelly Science and Clinical is hiring on behalf of one of our large CRO clients to support a six-month project with the potential for future extension. We are looking for strong CRA monitors to support regional studies at sites across the West Coast. Ideal candidates will have at least two years of experience monitoring complex therapeutic studies, with prior large CRO experience preferred. The CRA I performs and coordinates all aspects of the clinical monitoring and site management process. This role conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation across various monitoring environments (e.g., FSO, FSP, Government). As a site processes specialist, the CRA I ensures trials are conducted in accordance with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability while maintaining audit readiness. The CRA I develops collaborative relationships with investigational sites and project team members. Detailed tasks and responsibilities are outlined in the project task matrix. Bachelor's degree in a life science-related field, a Registered Nurse (RN) certification, or equivalent relevant academic/vocational qualification.2+ years of experience as a clinical research monitor or equivalent experience demonstrating the necessary knowledge, skills, and abilities. Prior monitoring experience complex therapeutic areas, with large CRO experience preferred. Valid driver's license. Effective clinical monitoring skills across full study lifecycles. Demonstrated understanding of medical/therapeutic area knowledge and medical terminology. Strong understanding and practical application of ICH-GCP guidelines, applicable regulations, and procedural documents. Well-developed critical thinking skills, including root cause analysis (RCA) and proactive problem-solving. Ability to apply Risk-Based Monitoring (RBM) concepts and processes. Clear oral and written communication skills with the ability to interact effectively with medical personnel and site staff. Strong customer focus with active listening skills, high attention to detail, and the ability to address underlying customer needs. Excellent interpersonal, organizational, and time-management skills. Ability to remain flexible and adaptable across a range of study scenarios. Proven ability to work effectively both independently and as part of a collaborative team. Computer proficiency, including Microsoft Office applications, with the ability to quickly learn EDC and CTMS platforms. Strong English language and grammar skills. Effective presentation and communication skills.
