Senior Clinical Research Coordinator

Golden State UrologyGolden State Urology was founded in 2007. Our Urology team has a combined 30+ years of experience in urology and continues to invest and implement the most advanced solutions and technology for all people. The team's expertise and specialty in urology provides the very best solutions for the patient through a personalized treatment plan to achieve optimal results.Job DescriptionLead and Manage clinical research at Golden State Urology. Conduct clinical research studies under the direction of the clinical Principal Investigator (PI) alongside the research team at Golden State Urology. Responsible for the execution of the trial, billing, and regulatory affairs for the entirety of the trial. In charge of the clinical research department at GSU.QualificationsInformed Consent and Protocol management skillsExperience in Clinical Research and Clinical TrialsExcellent organizational and multitasking abilitiesStrong attention to detail and accuracyEffective communication and interpersonal skillsAbility to work collaboratively in a team environmentBachelor's or Master's degree in a related fieldJob BenefitsPTO 401 KJob Accountabilities:Minimum Education: Bachelor's degree and Experience: 5 years Ability to work in Sacramento, Stockton, Fremont, and Folsom, CaliforniaBill for all clinical trial activities and ensure payments are receivedManage clinic's research schedulePerform patient visitsAdhere to clinical trial protocolsMinimum Field of Expertise: Experience working in a healthcare environmentDemonstrated ability to multitaskDemonstrated experience in a high volume, fast paced environmentDemonstrated team-oriented and collaborative work styleStrong interpersonal skillProficiency with Google Drive, Excel, EPIC, EDC systemsExperience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.Knowledge of medical terminology.Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferredAbility to perform basic medical assisting dutiesLeadership capabilitiesJob ResponsibilitiesWork with the principal investigator.Manage clinical research at Golden State Urology.Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.Bill for all study visits and ensure payments are being received. Meeting KPIs.Perform contracting duties including budget negotiations and CTAsOversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.Develop project schedules, targets, measurements, and accountabilities, as assigned. Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work. Managing research team's schedules.Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions.Correctly and efficiently abstracts information for source records and with attention to timeline requirements, enters accurate and complete data into the appropriate case report forms.Ensure timely data submission.Identifies and resolves any documentation discrepancies and queries.Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.Track patients and study specific milestones, and invoice sponsors according to the study contract.Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance.Conduct and document study visits and protocol-specific testing/interviews according to the study protocolComplete case report forms accurately and according to the protocolCompletes study procedures, as relevant to training and certificationResponsible for coordination, processing and quality control of clinical trial data.Review clinical trial data to ensure consistency, integrity and accuracy based on project guidelines.Other duties may also be assigned.Please attach cover letter with resume.

Created: 2025-03-03