The Regional Clinical Research Associate, II (West Coast), will be based in Texas, Arizona, Nevada, Colorado, this is a dedicated, in-house, home-based, sponsor role, 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 Regional Clinical Research Associate, II 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.
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 study reports, safety reports, and annual reports.
· Works independently with limited to no supervision
· 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 information documents, monitoring plans, informed consents, site training documents, and source document templates
· Assures strong productive relationships with study investigators, site staff, and study management personnel, including identification, assessment and resolution of existing relationship issues within assigned sites and other sites as required
· Front line user Systems Matter Expert on all Glaukos electronic and non-electronic study and data systems
· Provide internal and external training
· Deliver insight and expertise as a regional expert
· Leads department projects
· 8 years' work experience as a regional CRA; 10 years direct clinical research experience
· Must be willing and able to travel approximately 70-80%, including overnight, domestic and international.
· 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.