Avinger, Inc

Knowledge is power. The ability to see inside the artery during treatment gives physicians significantly more knowledge of the clinical problem and the power to do something about it in real-time. Avinger’s Lumivascular technology is radically changing the way vascular disease is treated. Through the CONNECT II and VISION trial, we were able to receive FDA clearance on both our CTO crossing catheter (Ocelot) and atherectomy catheter (Pantheris). Being able to see inside the artery with Optical Coherence Tomography (OCT) while performing the procedure is a real game changer. It allows the operator to make informed decisions for better long-term results while leaving normal arterial layers behind.

Vascular disease isn’t going away but at Avinger we continue to fight the progression and complications that result from PAD. We’ve won many battles, but the war goes on and we don’t take our responsibility to create change lightly. As our company ages, many of our ideas have become reality yet we still lie awake at night devising ways to do more. We know many are counting on us to do more. We continue to be an ordinary group of individuals trying to achieve the extraordinary. Avinger provides strong benefits, competitive compensation, and a friendly work environment.

Title: Clinical Research Associate

Location: Redwood City, CA

Role Overview:

Serve as a primary resource for clinical research activities by providing site management support including developing and maintaining relationships with physicians, nurses, and research coordinators during the course of an active clinical study. Work within federal and ICH guidelines for clinical studies pertaining to informed consent, data monitoring, HIPPA, and regulatory filings to support clinical study approvals. Attend, train, and monitor clinical studies in compliance with approved protocol and relevant regulatory requirements.

Duties:

Independently manage day to day operations of Clinical & Data Management activities

Maintain oversight of site and vendor performance, deliverables, issues, their resolution and coordinate corrective actions as necessary

Conduct Site Initiation Visits, Monitoring Visits and Close-Out Visits as necessary

Conduct Site Qualification Visits as necessary

Drive clinical study enrollment in accordance with the study schedule

Establish and maintain relationships with research coordinators and physicians to schedule cases and follow up at required intervals

Collect and maintain sound clinical data with good documentation practices and in compliance with regulatory requirements and SOP’s

Assist study sites in the resolution of CRF queries

Recognize and characterize reportable events, understanding reporting requirements and intervals

Assist with data analysis and create periodic reports for significant endpoints

Establish an efficient and organized system for monitoring study status

Maintenance of master clinical trial files and study trackers

Preparation of study binders and all related study materials for both in-house and clinical sites

Coordinate/assist with IRB submissions and IRB interaction

May assist with preparing clinical reports for 510(k)s and IDE’s

Assist with organization of Investigator meetings

Forecast and manage clinical inventory and supplies. Comply with product accountability procedures

Address non-compliance issues at investigative sites and develop corrective actions as necessary

Reconcile Site and Vendor invoices and track milestone payments in spreadsheets and other tools

Generate Purchase Order (PO) accounts

Provide updates to Senior Staff on clinical study progress

Up to 25% travel

Other duties as assigned.

Requirements:

Requires a BS, RN, or BSN degree is desired but not required

Must have 5+ years of experience in clinical research, working in a health care environment, industry, or CRO

Experience in vascular technology a plus, but not required

Must have a strong working knowledge of clinical research and familiar with requirements of regulatory agencies

Maintains frequent contacts with investigators and medical consultants to provide solutions to which arise during the course of clinical investigations

Excellent organizational skills

Excellent communication skills (written and verbal)

Avinger, Inc.