Principal Regional Clinical Research Associate
Glaukos is an ophthalmic medical technology company focusedon the development and commercialization of breakthrough products andprocedures designed to transform the treatment of glaucoma, one of the world'sleading causes of blindness. We have pioneered Micro-Invasive Glaucoma Surgery,or MIGS, to revolutionize the traditional glaucoma treatment and managementparadigm. We launched the iStent, our first MIGS device, in the United Statesin July 2012 and we are leveraging our platform technology to build acomprehensive and proprietary portfolio of micro-scale injectable therapiesdesigned to address the complete range of glaucoma disease states andprogression. We believe the iStent is the smallest medical device ever approvedby the Food and Drug Administration, or FDA, measuring 1.0 mm long and 0.33 mmwide.
The Regional Principal Clinical Research Associate (North East Coast), isa dedicated, in-house, home-based, sponsor role, based in Kentucky, Maine, NewJersey, Ohio, Pennsylvania or Virginia and will be responsible for assessingthe study capabilities of potential study sites, training, on-site monitoring,closure, and management of sites participating in clinical research studiessponsored by Glaukos. The Regional Principal Clinical Research Associate (CRA)may also assist in the development, analysis, and execution of a clinicalstudy. This job description attempts to capture only the primary and mostidentifiable tasks of this position.
CLINICAL RESEARCH MONITORING
· Travel to investigative sites to conduct sitequalification, initiation, interim monitoring and close-out visits.
· Verify informed consent procedures are properlyfollowed.
· Evaluate investigator compliance with the studyprotocol and applicable regulations.
· Verify sites are collecting all required sourcedata per protocol, accurately transcribing onto Case Report Forms, andresolving all data queries.
· Collect and submit CRFs and data queries to DataManagement vendor.
· Review the regulatory binder and essentialdocuments at the site and verify all documents are appropriately filed
· Verify essential documents are both filed in thesite's regulatory binder and the study master file as required.
· Capture, document, and communicate Adverse Eventinformation in accordance with the study protocol and regulatory requirements.
· Verify investigational product is properlystored, dispensed, and returned, and that accountability of the product andmasking requirements are maintained throughout the study.
· Assist with selection of potentialinvestigators.
CLINICAL SITE MANAGEMENT
· Maintain frequent contact with investigators andsite staff to monitor progress, answer questions, and provide guidance duringthe course of the clinical study.
· Assist site with development of essential studydocuments and IRB submissions/approvals. Verify all essential documents areproperly executed and prepared prior to shipment of investigational product.
· Prepare and verify proper execution of all requiredinvestigator agreements, including Non-Disclosure Agreement,
· Investigator Agreement, and CompensationAgreement.
· Purchase equipment for clinical sites asrequired by the study protocol and with management approval.
· Develop project plans (e.g., to increaseenrollment, motivational ideas, etc.), identify problems that interfere withstudy progress, and implement strategies to resolve issues.
· Prepare faxes, newsletters, and other forms ofcommunication to assist with enrollment and study compliance at clinical sites.
CLINICAL STUDY EXECUTION
· Be familiar with study timelines and budget, andcommunicate potential issues to management.
· Monitor and track study implementation andprogress, including provision of information to management for grant paymentsto the sites.
· Track, post on the shared drive, and fileessential documents in the study master file.
· Assist in preparation and planning forinvestigator meetings.
· May be responsible for or assist with managementof outside vendors, including Contract Research Organizations, Data Managementvendor, reading centers, CRF printers, etc.
· May mentor/train other CRAs and clinical staff,including assessing monitoring skills by traveling with the CRA to a sitevisit.
· May assist with the development of studyprotocols, investigator brochures, site-specific instruction manuals, casereport form designs, patient information documents, monitoring plans, informedconsents, site training documents, and source document templates.
· May participate in preparation of regulatorysubmissions necessary to initiate and maintain clinical studies and marketingapprovals, including clinical study reports, safety reports, and annualreports.
· Works independently with limited to nosupervision
· Mentor/train other CRAs and clinical staff,including assessment of monitoring skills by traveling with the CRA to a site visit
· Assist with the development of study protocols,investigator brochures, site- specific instruction manuals, subject informationdocuments, monitoring plans, informed consents, site training documents, andsource document templates
· Assures strong productive relationships withstudy investigators, site staff, and study management personnel, includingidentification, assessment and resolution of existing relationship issueswithin assigned sites and other sites as required
· Front line user Systems Matter Expert on allGlaukos electronic and non-electronic study and data systems
· Provide internal and external training
· Deliver insight and expertise as a regionalexpert
· Leads department projects
· 8 years’ work experience as a regional CRA; 10years direct clinical research experience
· Must be willing and able to travel approximately70-80%, including overnight, domestic and international.
· Bachelor's degree or equivalent experiencerequired in biological science, nursing, or other related area the bio-pharmaceutical or device industry, preferably within the ophthalmologyfield.
· Certified Clinical Research Associate (CCRA) orCertified Clinical Research Professional (CCRP) preferred.
We offer competitive salary (based on experience),bonus eligibility, medical/dental/vision, life insurance, stockoptions, 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 inour community, plus the opportunity to work for a company that ispioneering a new glaucoma treatment class. Check out our profile on TheMuse to get an inside look at our company culture: https://www.themuse.com/companies/glaukoscorporation
Glaukos has been recognized by the Orange CountyBusiness Journal as one of the best companies to work for in in OrangeCounty, check out page 8 at http://www.cbjonline.com/a1ocbj/lists/List-2017-OC_Best-Places-to-Work.pdf
GlaukosCorporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receiveconsideration for employment without regard to race, color, religion, sexincluding sexual orientation and gender identity, national origin, disability,protected Veteran Status, or any other characteristic protected by applicablefederal, state, or local law.