Monitoring of studies, verification and data collection for clinical trials in accordance with Sponsor SOPs, study protocol, Good Documentation Practices (GDP), Good Clinical Practices (GCP) and regulatory requirements.
Assisting with various aspects of Clinical Trial activities including preparation of trial-related documents, organizing site initiation meetings with site research personnel and assisting in start-up activities (i.e. supplying sites with trial-related documents, collection and audit of site regulatory documents to ensure site has appropriate approvals and documents in order to conduct the study).
Provide oversight and ensure investigator/site compliance (i.e. trending of protocol compliance/deviations, monitoring data quality, ensuring site compliance to IRB/EC and Competent Authority/Regulatory (i.e. FDA) policies
Review and validate investigational device accountability by maintaining traceability and tracking the history of investigational device from Neuros Medical to clinical sites (placing and processing device order for field sites through final disposition).
Collaborate with team members to develop and deliver training on protocols, databases, adverse event reporting, GCP and GDP.
Audit/review internal and external logs (i.e. device accountability, training, delegation of authority (DOA).
A bachelor’s degree or a minimum of 2 years equivalent clinical experience is required. A degree in a related biological, life science discipline or in nursing and/or clinical research is preferred.
1-2 years prior hands-on clinical research experience including previous field or in-house monitoring is preferred.
Clinical Research Certification (i.e. ACRP, CRA Certification) is preferred.
Experience working in a medical device or regulated industry is preferred.
Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required.
Substantial computer literacy in Microsoft Office Suite is required (Word, Excel, and PowerPoint).
General understanding of anatomy, pathology and physiology is preferred.
General understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting is preferred.
Technical writing skills (protocols, CRF development, study tools) are preferred.
Ability to communicate and relate well with clinical personnel and/or key opinion leaders is required.
Additional Salary Information: Exempt, full time position. Salary based on level of experience.
Internal Number: CA-002
About Neuros Medical, Inc.
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, chronic post-surgical pain, and chronic migraine.
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.