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Sr Clinical Research Associate Multiple Positions

2 weeks ago

united states Glaukos Corporation Full time

We are a medical technology and pharmaceutical company that’s advancing the treatment of ophthalmic diseases. At Glaukos, we are pioneering new treatments for chronic eye diseases and are focused on novel therapies for the treatment of glaucoma (market-leader iStent inject® W), corneal disorders and retinal diseases. We have an amazing culture that fosters opportunities for growth, excellent benefits, great pay, and are Great Place to Work Certified.   We're looking for a Sr. Clinical Research Associate to join our team. This is an opportunity to be part of a team that takes pride in leading the way in our business and our community - we dare to dream, dare to lead, and dare to care. If you want to be part of this exciting work, you belong at Glaukos How will you make an impact?    The Clinical Research Associate (CRA) is 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 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. Salary Range: $94,800 - $123,300. (plus bonus , equity etc.) CLINICAL SITE MONITORING Oversee and conduct monitoring activities. Investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits. Assist with selection of potential investigators. Conduct initial and ongoing site training throughout the course of the study.  Verify informed consent process is properly followed. Evaluate investigator compliance with the study protocol and applicable regulations. Verify sites are collecting all required source data per protocol, accurately completing Case Report, Forms, and resolving all data queries. Verify and reconcile site’s essential documents against the trial master file. Verify investigational product is properly stored, dispensed, returned. CLINICAL SITE MANAGEMENT Guide/manage assigned sites.  Critically review and access site activities.  Build relationships with the Investigators and site staff. Collaborate with study management on protocol discrepancies, improving efficiency, and monitoring data integrity. Manage the progress of assigned studies by tracking subject enrollment, data collection, CRF completion, source data verification, data query generation and resolution, and investigational product accountability. Monitor subject safety and address protocol deviations, data quality issues, and drug accountability. Create and maintain appropriate documentation (e.g., visit reports/letters) regarding site management, monitoring visit findings, and action plans. Ensure audit and inspection readiness. Advise on pre-audit activities for GCP requirements. Regional Sr CRA:   5 years of work experience as a regional CRA; 8 years direct clinical research experience. Minimal supervision. Mentor/train new CRAs. Provide FDA inspection support. Maintain strong productive relationships with study investigators, site staff, and study management personnel. Participate in the development of source document templates, CRFs, CRF completion guidelines, and monitoring. Bachelor's degree in biological science, health science, nursing, health related area, or equivalent clinical experience required. Knowledge of Good Clinical Practices (ICH E6 R2). Knowledge of FDA’s Code of Federal Regulations applicable to conducting clinical research studies.        Proficient computer skills and experience with Microsoft Office. Travel approximately 70%, including overnight, domestic and international. Experience in the medical device and pharmaceutical industry is preferred. Ophthalmology experience is strongly preferred for all levels of a CRA. Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.    These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.  Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we’re a rapidly growing company with a dynamic, fast-paced culture, individual employees are empowered with more diverse and enriching challenges that might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.  We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, generous time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class Glaukos Corporation has been Certified as a Great Place to Work the last two years  Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.