Senior Clinical Research Associate

Role Overview We are seeking a Senior Clinical Research Associate (CRA) to support our Clinical Operations team. The Senior CRA will be responsible for overseeing clinical trial site management and monitoring activities to ensure compliance with ICH-GCP, regulatory requirements, and company SOPs. In this role, you will partner closely with clinical sites and cross‑functional teams to support high‑quality study execution, patient recruitment, and operational excellence across clinical trials. Responsibilities Conduct all clinical monitoring activities, including site qualification, initiation, routine monitoring, and close‑out visits. Support site feasibility, site selection, and ongoing site management activities throughout the clinical trial lifecycle. Review clinical trial progress, patient recruitment, and data quality metrics, and implement actions to support study objectives. Maintain accurate and timely monitoring documentation, including trip reports and trial master file records. Collaborate with vendors, clinical sites, and cross‑functional teams to support study execution and operational compliance. Participate in investigator meetings, clinical trial documentation development, and study team meetings. Mentor junior CRA team members and contribute to continuous improvement of clinical operations processes and procedures. Travel up to 75% of the time; a valid driver’s license is preferable. Basic Qualifications Bachelor’s degree in life sciences, nursing, or a related field. 4+ years of on‑site monitoring experience within the pharmaceutical or biotechnology industry, including all clinical monitoring visit types. Strong knowledge of ICH‑GCP, FDA, EMA, and applicable clinical trial regulations. Demonstrated experience managing clinical trial sites, monitoring activities, and clinical trial documentation. Proficiency with clinical trial systems and tools (e.g., CTMS, eTMF, Microsoft Office). Preferred Qualifications Experience in oncology clinical trials or related therapeutic areas. Advanced presentation, organizational, and stakeholder management skills. Experience mentoring or training junior CRAs and supporting cross‑functional clinical operations activities. Demonstrated ability to drive quality, efficiency, and continuous improvement initiatives in clinical operations. Strong understanding of clinical trial recruitment strategies, data capture, and site engagement best practices. Experience contributing to global harmonization, process optimization, or operational innovation initiatives. Benefits Competitive rates for health, dental, and vision insurance. 4 weeks of vacation, granted upfront each year and prorated for the first and last year of employment. 12 company‑paid holidays. 7 days of sick time. 100% employer‑paid life insurance up to 1x annual salary, up to $100,000. 100% employer‑paid short‑ and long‑term disability coverage. 401(k) with immediate eligibility and a company match: 100% match up to 3% of base salary for the first two years, 4% for years 2‑3, and up to 5% from the fourth year onward. Partially paid parental leave for eligible employees. Additional voluntary employee‑paid benefits and services, including accident, hospital indemnity, critical illness insurance, identity theft protection, and pet insurance. Equal Employment Opportunity We are an equal opportunity employer and are committed to building a diverse and inclusive workplace. We consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, national origin, ancestry, age, marital status, disability, genetic information, veteran status, or any other status protected by applicable law. Reasonable Accommodations We are committed to providing reasonable accommodations to individuals with disabilities and to applicants with sincerely held religious beliefs, practices, or observances. If you require assistance or accommodation during the application or interview process, please contact us at View email address on click.appcast.io. Work Authorization Applicants must be authorized to work in the United States without the need for current or future sponsorship. Visa sponsorships may be available for certain roles. #J-18808-Ljbffr