Clinical Training Supervisor

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, 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 platform, Translational Pharmaceutics®, integrates Drug Product Manufacturing and Clinical Testing to reduce costs, improve outcomes, and accelerate drug development times.

About the role

Responsible for ensuring training of all new hires in GCP, health and safety procedures, and other required orientation. You will train Clinical Operations staff on clinical procedures, maintain up-to-date documentation, and oversee mandatory training, licensure, and certification for clinical/medical teams. This role includes oversight of Clinical Research Technicians, ensuring subject safety, high clinical standards, and high-quality study data collection in accordance with ICH–GCP. You will also support the development, implementation, monitoring, and management of operational systems while adhering to applicable regulations.

Responsibilities

• Oversee 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 on clinical procedures, source documentation, equipment use and calibration, and relevant industry guidelines and federal regulations.
• Liaise with functional heads, Clinic Manager, and Clinical Leads to identify training needs.
• Assess competencies and communicate staff readiness to the scheduling department.
• Oversee and provide refresher training to clinical staff as necessary.
• Respond to Quality Issues and audits related to trials; assist with investigations of quality events and identify appropriate CAPAs (related to training).
• Provide support for BLS/ACLS scenario training.
• Write, update, and review SOPs and relevant working instructions.
• Work with facilities to ensure timely preventative calibration of clinical equipment.
• Oversee validation activities of clinical equipment; assist clinical leads in procurement of study-specific equipment.
• Assist 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 the clinical unit operates according to current best clinical practice and updates policies to comply with regulations.
• Participate in weekly call rotation to supervise clinical activities.
• Manage Clinical Research Technicians and perform clinical procedures as applicable under scope of practice for licensed professionals (e.g., RN, LPN, ARNP, PA, MD, EMT).
• Support PM and commercial teams during site visits to promote new business opportunities.
• Identify opportunities for change and assist with implementation of process improvements.
• Perform ad hoc duties to support ongoing operations.

Requirements

• Bachelor’s degree or equivalent qualified experience in a healthcare setting.
• Minimum 2 years of 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.
• Attention to detail, excellent communication, and organizational skills.
• Proficiency in Microsoft programs (e.g., Excel, Word, PowerPoint).
• Excellent verbal, non-verbal, and written communication skills.
• Strong interpersonal and customer service skills.
• Ability to speak Spanish (preferred).

Job Demands

• Very high concentration of work with strict and tight deadlines.
• Juggling a range of tasks/issues simultaneously.
• Working in a hazardous environment with a high requirement to follow safety procedures.
• Working outside normal working hours.
• Responding to client demands.

Candidates must be aged 18 years or over and not debarred by the FDA.