Clinical Training Supervisor

Quotient Sciences•Miami, FL

8d•Onsite

About The Position

Responsible for ensuring training of all new hires in GCP, receiving 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.

Requirements

Bachelors degree or equivalent qualified experience in a healthcare setting.
Minimum 2 years work experience within a Clinical research environment preferred
Experience in training colleagues 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

Responsibilities

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