Cypress HCM

Compensation

Full Description

Responsibilities: • Assess unexpected events or process deviations at clinical sites and determine patterns or areas needing improvement. Work with sites, external partners, and vendors to establish corrective approaches that support subject safety, data integrity, and study compliance. • Evaluate visit documentation from site monitors, confirm that follow-up actions are completed, and elevate significant concerns or risks when needed. • Take part in scheduled study data checks and oversee day-to-day site oversight activities to ensure high-quality data and timely updates. • Conduct continuous review of study documentation, including data outputs, essential files, and other trial records. • Identify operational challenges early and contribute solutions that protect timelines, quality, and budget. • Provide training and guidance to both internal and outsourced monitoring teams, as well as site staff. • Support the tracking, interpretation, and presentation of operational metrics under the direction of senior clinical leadership. • Oversee performance of contract partners and vendors using pre-defined indicators to confirm adherence to contracted expectations. • Maintain ongoing awareness of site adherence to study requirements and good clinical practices. • Ensure remediation plans are drafted and implemented when operational issues arise. • May participate in qualification, activation, routine monitoring, or study-close activities on an as-needed basis. • Maintain organized oversight files for study teams. • Confirm availability of needed study materials, systems, and supplies (e.g., contracts, randomization systems, lab materials, and supporting study tools). • Contribute to departmental efficiency or process-improvement initiatives. • Assist with reviewing vendor billing and cost-related documentation. Qualifications: • Bachelor’s degree (or equivalent experience) in a scientific or related area. • Approximately five or more years of hands-on experience within clinical research operations (experience level dependent on education/training). • Strong preference for candidates with background supporting oncology studies. • Broad understanding of end-to-end clinical trial operations and cross-functional workflows. • Ability to interpret and apply international regulatory expectations to trial conduct. • Solid working knowledge of good clinical practice standards and ICH guidelines. Starting as a 6 month contract with potential to convert to a full time permanent position