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
#INDHP
Application RequirementsWhen applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.
