Position Summary:

Initiate, train and coordinate clinical study activities that may include training of investigators on both the study protocol and the company’s technology. Preparation of clinical study documents including study protocols, CRFs, investigator brochures and other study documents. Preparation for clinical studies, including: investigator selection and investigator meetings, budget planning and review, contract preparation, vendor selection and site selection. Manage study activities that may include oversight of CROs, core labs, and/or other vendors, reporting on study status, and ensuring timely completion within budget. Train vendors and clinical sites to ensure adherence to the protocol and compliance with ICH/GCP Guidelines. Assist in preparation of clinical study reports for regulatory submissions and scientific publications.

Core Job Responsibilities:

Planning and execution of pre-market and post-market clinical studies to support regulatory filings, marketing objectives or other goals of the organization
Preparation of study protocols, case report forms and other essential study-related documentation
Drive clinical study enrollment in accordance with the study schedule and ensure timelines are being driven in accordance with the goals of the organization
Drive IRB, EC and country approval filings to ensure timely initiation of study commencement
Preparation of literature reviews as necessary
Assist in the development of clinical study budgets
Preparation of clinical trial agreements and negotiation of clinical study budgets with sites
Develop an efficient and organized system for updating Senior Staff on clinical study progress
Act as a liaison between physicians and engineers to provide feedback on clinical products including reporting and documentation of customer complaints
Planning and execution of investigator meetings
Prepare clinical study reports to support regulatory filings
Manage CRAs or Jr. CRAs or other clinical administrative personnel
Review and sign-off of monitoring visit reports
Preparation of monitoring plans
Review and oversight of data management activities.
Execution and management of CEC/DSMB Committees activities as required
Up to 50% travel
Other duties as assigned

Requirements:

Strong working knowledge of company technology and ability to proctor physicians in a catheter lab setting is a must
Excellent Project Management skills
Requires a BS, RN, or BSN degree is desired but not required
Must have 7+ years of experience in clinical research, working in a health care environment, industry, or CRO
Must have a strong working knowledge of clinical research and familiar with requirements of regulatory agencies
Experience in vascular technology a plus, but not required
Clinical writer – ability to write reports, protocols, publications, a plus, but not required

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.

Avinger, Inc.