Clinical Training Supervisor

Quotient Sciences•Miami, FL

8d•Onsite

About The Position

Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing. Our proprietary and disruptive platform – “Translational Pharmaceutics®” – integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times. Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact—fast.

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.
Must be aged 18 years or over.
Must not have been debarred by the FDA.

Nice To Haves

Minimum 2 years work experience within a Clinical research environment.
Experience in a Clinical Research environment.

Responsibilities

Ensuring training of all new hires in GCP, receive training for health and safety procedures, and other required orientation.
Training Clinical Operation staff on clinical procedures and ensuring documentation and training are up to date for all Clinical Operations staff.
Planning, tracking and follow up of mandatory training, licensure and certification for clinical/medical teams.
Oversight of Clinical Research Technicians.
Ensuring subject safety at all times.
Ensuring excellent clinical standards within the clinic.
Ensuring study data is collected to a high quality in accordance with ICH–GCP.
Providing support in the development, implementation, monitoring and management of various operational systems by adhering to applicable regulations.
Complying & adhering to GCP guidelines and regulations as required.
Overseeing validation and maintenance of clinical equipment (e.g. telemetry systems, IV pumps).
Serving as a Subject Matter Expert for source data collection systems, including TrialOne.
Maintaining and updating the clinical training matrix; assisting with collation of training metrics.
Training and managing training of clinical staff.
Organizing, planning and providing 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).
Liaising with functional heads, Clinic Manager and Clinical Leads to identify training needs.
Assessing competencies and communicating with the scheduling department of readiness of staff.
Communicating with the line managers on progression of training of new hires.
Overseeing/providing update and/or refresher training to clinical staff when necessary.
Responding to Quality Issues and audits related to trial; assisting with investigations of quality events and identifying appropriate CAPAs (those related to training).
Providing support for BLS/ACLS scenario training.
Writing, updating and reviewing SOPs and relevant working instructions where required.
Working with facilities to ensure preventative calibration of clinical equipment is performed timely.
Overseeing the validation activities of clinical equipment; assisting the clinical leads in procurement of study specific equipment.
Assisting with QA and sponsor audits.
Working with Clinical Manager and environmental Health and Safety Specialist to undertake self-inspections of facility and clinical areas.
Completing clinical department monthly workplace inspections.
Ensuring clinical unit is working to current best clinical practice, updating policies and procedure to comply with current regulations.
Participating in weekly call rotation to supervise clinical activities.
Managing position of Clinical Research Technicians.
Performing clinical procedures as applicable under scope of practice for licensed professional (e.g. RN, LPN, ARNP, PA, MD, EMT).
Supporting PM and commercial team in general site visits to promote new business opportunities.
Identifying opportunities for change and assisting with implementation of process change.
Performing ad hoc duties as required to support ongoing operations.