Job Details

How will you make an impact?Responsible for assessing the study capabilities of potential study sites, training, on‑site monitoring, closure, and management of sites participating in clinical research studies sponsored by Glaukos. The SR. Clinical Research Associate (CRA) is responsible for maintaining data integrity and monitoring study conduct in accordance with regulations and the study protocol at the site level.What will you do?CLINICAL SITE MONITORINGTravel to investigative sites to conduct site qualification, initiation, interim monitoring, and close‑out visitsAssist with selection of potential investigatorsConduct initial and ongoing site training throughout the course of the study; verify informed consent process is properly followedEvaluate investigator compliance with the study protocol and applicable regulationsVerify sites are collecting all required source data per protocol, accurately completing Case Report Forms, and resolving all data queriesReview the regulatory binder and essential documents at the site and verify all documents are appropriately filedVerify and reconcile site's essential documents against the trial master file as requiredOversee and conduct monitoring activities, including remote monitoring when applicableVerify investigational product is properly stored, dispensed, returned, and that accountability of the product and masking requirements are maintained throughout the studyCLINICAL SITE MANAGEMENTAssign sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical studyCritically review and analyze site activities through frequent visits and contacts to monitor study sites and performanceBuild relationships with investigators and site staff to enhance productivity, and collaborate with study management on protocol discrepancies, improving efficiency, and monitoring data integrityManage the progress of assigned studies by tracking subject enrollment, data collection, CRF completion, source data verification, data query generation and resolution, and investigational product accountabilityMonitor subject safety and address protocol deviations, data quality issues, drug accountability, and identify process improvements for assigned sitesCreate and maintain appropriate documentation (e.g., visit reports/letters)Work independently with seldom supervisionMentor/training new CRAsConduct peer‑to‑peer review visitsProvide FDA inspection supportMaintain strong productive relationships with study investigators, site staff, and study management personnel, and resolve existing relationship issuesParticipate in the development of source document templates, CRFs, CRF completion guidelines, monitoring plans, etc.Execute department projectsHow will you get here?Clinical coordinating experience in ophthalmology requiredDegree in biological science, nursing, or other related discipline preferred, or direct work experienceExperience in the medical device and pharmaceutical industry preferred, and ophthalmology experience strongly preferred for all levelsKnowledge and understanding of Good Clinical Practices (ICH E6 R2)Knowledge and understanding of FDA's Code of Federal Regulations applicable to conducting clinical research studiesMust have proficient computer skills and experience with Microsoft OfficeMust be willing and able to travel approximately 75‑80%, including overnight, domestic and internationalMust have self‑directed behaviorIdeally will be located in Western US#J-18808-Ljbffr