Description
Key Features --Writes/reviews protocols, study reports, and other materials
-Works with CA management to develop clinical study strategies
-Develops clinical SOPs.
-Maintains current knowledge of clinical regulations and standards (including changing regulations). Creates and implements regular process improvements.
-Represents the clinical department at project team meetings
-Designs, plans, conducts, and monitors clinical studies
-Conducts site qualification activities
-Conducts site initiation visits
-Works with CROs, as needed to meet business objectives
- Implements strategies for enrollment to ensure timely completion of clinical studies, in alignment with department and corporate strategic objectives (newsletters, conference calls, emails, etc).
- Produce study summaries for Clinical Affairs management, including reports, graphs and tables, as requested.
-conducts budget negotiations with clinical sites.
-Works independently to manage all clinical tasks and deliverables to meet clinical timelines
-Serves as product expert (e.g. subject matter expert) for the specific product line assigned.
-Collaborates with Marketing to develop marketing claims studies
-Collaborates effectively with peers and leadership across departments and can professionally interact/build relationships with FDA, IRB, and key opinion leaders
-Assists with Clinical Finance requirements and reporting
-Assesses clinical investigators, study staff, and contract research organizations (if applicable) for compliance with study protocols, regulations, and Standard Operating Procedures. Implements appropriate corrective action as needed
-Writes clinical study reports for inclusion in regulatory submissions and develops clinical study materials (including, but not limited to, source documentation, CRFs, IRB submissions, training slides, etc.)
-Researches and collects information on regulatory/clinical requirements and standards.
Education / Experience -
- Bachelor's degree, in a life science or health-related field; nursing or diabetes experience desirable.
- 5-7 years CRA experience
- Experience working in the medical device industry preferred
- Involvement in regulated medical device studies, with a knowledge base of medical device regulations.
- Professional certification (e.g. ACRP, SoCRA) considered a plus.