Responsible for many aspects of clinical operations including monitoring of clinical sites with moderate subject enrollment, ensuring compliance with Sponsor SOPs, study protocol, eDiary reporting and compliance, Documentation Practices (GDP), Good Clinical Practices (GCP) and regulatory requirements. Establishing trackers and maintaining regulatory documents, collaborating with management in the development of clinical study protocols, case report forms and other study documentation. Interacting with site investigators, research coordinators and field monitors. Providing training to site research staff as well as training and mentoring colleagues with less experience. Developing reports and providing quarterly updates to Clinical Management Team; assisting in audit preparation and ensuring compliance at clinical sites.
A bachelor’s degree or a minimum of 5 years equivalent clinical experience is required. A degree in a related biological, life science discipline or in nursing and/or clinical research is preferred.
A minimum of five (5) years hands-on clinical research experience.
Experience working in a medical device or regulated industry.
Good understanding of regulatory documents, monitoring, Electronic Data Capture (EDC) systems, eDiary experience, device accountability, and adverse events reporting.
Technical writing skills (protocols, CRF development, study tools).
Excellent communication, writing, presentation and analytical skills.
Substantial computer and database literacy in Microsoft Office Suite.
Clinical research certification is preferred (ACRP or CRA certification).
Neuros Medical, a Cleveland, Ohio based neuromodulation company, is focused on developing proprietary therapies for unmet needs to patients worldwide. The Company's patented platform technology, Electrical Nerve Block, is focused on elimination of chronic pain in a variety of applications including neuroma/residual limb pain.
Neuros Medical's technology, delivers high-frequency stimulation to sensory nerves in the peripheral nervous system to block chronic pain. The system consists of an electrode (also known as a lead) placed around a peripheral nerve and powered by a pacemaker-size generator.
CAUTION -- Investigational device. Limited by Federal (or United States) law to investigational use.