Position Summary:

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.

Core Job Responsibilities:

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
Manage clinical inventory and comply with accountability procedures
Address non-compliance issues at investigative sites and develop corrective actions as necessary
Up to 50% travel

Other Responsibilities:

Understand the job specific quality system procedures and processes as defined in the Training Matrix and adhere to the requirements listed in those documents.
Maintain corporate confidentiality at all times.

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.