Under general direction from the Sr. Director of Clinical & Regulatory Affairs, the CA/RA Manager will be responsible for the operational execution of assigned clinical trials. The employee is expected to develop and foster clinical study site and team relationships to ensure high quality site performance and GCP compliance. The employee will oversee day-to-day aspects of clinical trial activities and operations such as site screening, site selection, enrollment, initiation, monitoring and close-out visits, oversee production of Study Reference Manuals and all required study materials including case report forms, protocols, instructions for use, study operations manuals, site and annual reports. They will be responsible for managing the recruitment, development and appraisal of internal clinical staff including implementation and execution of departmental procedures and directives. In addition, in conjunction with senior level oversight, supervising deliverables of vendors (e.g., CRO, data management, eDiary platform) to facilitate effective communication and efficient interaction.
The employee will participate in all relevant and required SOP and in-house training seminars and will be responsible for ensuring that all training is current for therapeutic area, and global/local clinical research guidelines and regulations.
A bachelor’s degree is required. A master’s degree or higher education is preferred. A degree in a related biological, life science discipline or in nursing and/or clinical research is preferred.
Knowledge of Good Clinical Practices, ICH guidelines, FDA 21 CFR Regulations, ISO 14155, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based).
Thorough understanding of the clinical research and medical device development process.
Ability to travel up to 25%.
Required minimum of 5 years hands-on clinical and regulatory experience in a medical device company conducting IDE and PMA clinical trials.
Excellent written and verbal communication skills, presentation skills, interpersonal and analytical skills.
Previous experience of site monitoring and study management preferred.
Additional Salary Information: Salary based on level of experience.
Internal Number: CA-RA-005
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.
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.