Clinical Training Supervisor

The Role: Responsible for ensuring training of all new hires in GCP, receive training for health and safety procedures, and other required orientation.  Responsible for training Clinical Operation staff on clinical procedures and ensuring documentation and training are up to date for all Clinical Operations staff.    Responsible for planning, tracking and follow up of mandatory training, licensure and certification for clinical/medical teams.   Responsible for oversight of Clinical Research Technicians  Responsible for ensuring subject safety at all times  Responsible for ensuring excellent clinical standards within the clinic  Responsible for ensuring study data is collected to a high quality in accordance with ICH–GCP  Responsible for providing support in the development, implementation, monitoring and management of various operational systems by adhering to applicable regulations.  To comply & adhere to GCP guidelines and regulations as required.  Main Tasks and Responsibilities: Responsible for overseeing validation and maintenance of clinical equipment (e.g. telemetry systems, IV pumps)  Serve as a Subject Matter Expert for source data collection systems, including TrialOne  Maintain and update the clinical training matrix; assist with collation of training metrics  Train and manage training of clinical staff.  Organize, plan and provide initial and ongoing training as required by the operations (i.e. clinical procedures, source documentation, equipment use and calibration, relevant industry guidelines and federal regulations) Liaise with functional heads, Clinic Manager and Clinical Leads to identify training needs   Responsible for assessing competencies and communicating with the scheduling department of readiness of staff.   Communicate with the line managers on progression of training of new hires  Oversee/provide update and/or refresher training to clinical staff when necessary.  Respond to Quality Issues and audits related to trial; assist with investigations of quality events and identify appropriate CAPAs (those related to training)  Provide support for BLS/ACLS scenario training   Writing, updating and reviewing SOPs and relevant working instructions where required   Work with facilities to ensure preventative calibration of clinical equipment is performed timely   Oversee the validation activities of clinical equipment; assist the clinical leads in procurement of study specific equipment  Assisting with QA and sponsor audits  Work with Clinical Manager and environmental Health and Safety Specialist to undertake self-inspections of facility and clinical areas  Complete clinical department monthly workplace inspections.   Ensure clinical unit is working to current best clinical practice, updating policies and procedure to comply with current regulations  Participate in weekly call rotation to supervise clinical activities  Manage position of Clinical Research Technicians  Clinical procedures as applicable under scope of practice for licensed professional (e.g. RN, LPN, ARNP, PA, MD, EMT)  Support PM and commercial team in general site visits to promote new business opportunities   Identify opportunities for change and assist with implementation of process change  Perform ad hoc duties as required to support ongoing operations  The Candidate: Minimum qualifications – Bachelors degree or equivalent qualified experience in a healthcare setting.   Minimum 2 years work experience within a Clinical research environment preferred   Experience in training collegues on clinical procedures and processes  Experience in SOP and process design   Understanding of the clinical development process and clinical safety documentation requirements  Proactive approach to GCP and clinical safety compliance  Experience in a Clinical Research environment preferred  Attention to detail, excellent communication and organizational skills  Experience of Microsoft associated programs (eg. Excel, Work, PowerPoint)  Excellent verbal, non-verbal and written communication skills.  Excellent interpersonal and customer service skills  Job Demands: The job may involve the following:  Very high concentration of work  Strict and tight deadlines  Having to juggle a range of tasks/issues simultaneously  Working in a hazardous environment with high requirement to follow safety procedures  Working outside normal working hours  Needing to respond to client demands