Responsibilities: for the Senior Clinical Research Associate include: · Independently monitoring Phase II-III Oncology clinical trials to ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements. · Conducting site initiation, routine monitoring, and closeout visits while maintaining high-quality oversight of investigative sites. · Performing source data review (SDR), source data verification (SDV), and case report form (CRF) review to ensure accurate and inspection-ready study data. · Building strong partnerships with investigative sites to support enrollment goals, protocol adherence, and overall study success. · Collaborating directly with sponsors, study teams, and site personnel while providing regular updates on site performance and trial progress. Qualifications: for the Senior Clinical Research Associate include: · 4+ years of Clinical Research Associate experience, including significant experience independently monitoring Oncology clinical trials. · Strong knowledge of ICH-GCP guidelines, FDA regulations, clinical trial operations, and site management best practices. · Experience supporting Phase II and Phase III studies with responsibility for site oversight, monitoring, and issue resolution. · Proven ability to conduct site initiation, interim monitoring, and closeout visits independently. · Strong sponsor-facing communication skills and experience working directly with biotechnology or pharmaceutical clients. · Ability to manage multiple investigative sites, prioritize competing demands, and work effectively with minimal supervision. · Must be located within reasonable distance of a major airport and willing to travel regionally as required. Compensation: for the Senior Clinical Research Associate includes: · Salary range: $120,000 - $145,000 · Comprehensive benefits package including Medical, Dental, Vision, 401k, PTO, holidays, and sick leave as required by law.
| Location | Columbus, OH |
| Salary | $120,000–$145,000 Per Year |
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