Regional Clinical Research Associate
Glaukos is an ophthalmic medical technology company focused on the development and commercialization of breakthrough products and procedures designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. We launched the iStent, our first MIGS device, in the United States in July 2012 and we are leveraging our platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. We believe the iStent is the smallest medical device ever approved by the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mm wide.
The Regional Clinical Research Associate, regionally field-based, in Chicago, Boston or New York will be 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) may also assist in the development, analysis, and execution of a clinical study. This job description attempts to capture only the primary and most identifiable tasks of this position.
CLINICAL RESEARCH MONITORING
· Travel to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits.
· Verify informed consent procedures are properly followed.
· Evaluate investigator compliance with the study protocol and applicable regulations.
· Verify sites are collecting all required source data per protocol, accurately transcribing onto Case Report Forms, and resolving all data queries.
· Collect and submit CRFs and data queries to Data Management vendor.
· Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed
· Verify essential documents are both filed in the site's regulatory binder and the study master file as required.
· Capture, document, and communicate Adverse Event information in accordance with the study protocol and regulatory requirements.
· Verify investigational product is properly stored, dispensed, and returned, and that accountability of the product and masking requirements are maintained throughout the study.
· Assist with selection of potential investigators.
· FOR PRINCIPAL - In addition to responsibilities above, a Principal CRA serves as regional expert on clinical and protocol matters.
CLINICAL SITE MANAGEMENT
· Maintain frequent contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study.
· Assist site with development of essential study documents and IRB submissions/approvals. Verify all essential documents are properly executed and prepared prior to shipment of investigational product.
· Prepare and verify proper execution of all required investigator agreements, including Non-Disclosure Agreement,
Investigator Agreement, and Compensation Agreement.
· Purchase equipment for clinical sites as required by the study protocol and with management approval.
· Develop project plans (e.g., to increase enrollment, motivational ideas, etc.),identify problems that interfere with study progress, and implement strategies to resolve issues.
· Prepare faxes, newsletters, and other forms of communication to assist with enrollment and study compliance at clinical sites.
CLINICAL STUDY EXECUTION
· Be familiar with study timelines and budget, and communicate potential issues to management.
· Monitor and track study implementation and progress, including provision of information to management for grant payments to the sites.
· Track, post on the shared drive, and file essential documents in the study master file.
· Assist in preparation and planning for investigator meetings.
· May be responsible for or assist with management of outside vendors, including Contract Research Organizations, Data Management vendor, reading centers, CRF printers, etc.
· May mentor/train other CRAs and clinical staff, including assessing monitoring skills by traveling with the CRA to a site visit.
· May assist with the development of study protocols, investigator brochures, site-specific instruction manuals, case report form designs, patient information documents, monitoring plans, informed consents, site training documents, and source document templates.
· May participate in preparation of regulatory submissions necessary to initiate and maintain clinical studies and marketing approvals, including clinical studyreports, safety reports, and annual reports.
· CRA: At least 2 years work experience as a CRA; 5 years direct clinical research experience.
· SR CRA: At least 5 years work experience as a CRA; 8 years direct clinical research experience.
· Principal: At least 8 years work experience as a CRA; 10 years direct clinical research experience.
· Experience in the medical device industry is preferred, and ophthalmology experience is strongly preferred for all levels
of a CRA.
Knowledge and understanding of ICH E6:
· Good Clinical Practices
· Knowledge and understanding of FDAs Code of Federal Regulations applicable to conducting clinical research studies
· Must have proficient computer skills and experience with Microsoft Office
· Must be willing and able to travel approximately 70-80%%, including overnight, domestic and international.
· Senior - In addition to those items listed under CRA Have conducted all types of site visits
· Have mentored or been involved in the training of another CRA or clinical assistant
· Principal - In addition to those items listed under CRA and Senior: Proven ability to provide insight and expertise as a regional expert and Strong site relationship expertise.
· Bachelor's degree or equivalent experience required in biological science, nursing, or other related area the bio- pharmaceutical or device industry, preferably within the ophthalmology field.
· Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP) preferred.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, 3 weeks paid time off, 13 company paid holidays, Employee Stock Purchase Program and 2 additional paid days off to volunteer in our community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class. Check out our profile on The Muse to get an inside look at our company culture: https://www.themuse.com/companies/glaukoscorporation
Glaukos has been recognized by the Orange County Business Journal as one of the best companies to work for in in Orange County, check out page 8 at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf
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.