The Role

• Responsible for reviewing with the Onboarding team all required regulatory training including but not limited to CITI: OSHA, GCP and GDP, Trilogy Med-waste and KnowB4 trainings have been completed during scheduled onboarding prior to commencing Clinical Competencies in the Clinic.
• Responsible for conducting delegated training of Clinical Research Technicians on clinical procedures and assisting the Clinical Training Supervisor in ensuring documentation and trainings are up to date for all Clinical Operations personnel.
• 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 

• Liaise as required by delegation with functional heads, Director of Clinical Operations, Clinical Training Supervisor and Clinical Leads to identify training needs.
• Complete delegated clinical training for newly hired Clinical Research Technicians and assist Clinical Training Supervisor to manage ongoing Bi-Annual Clinical Competency Re-Evaluations of clinical personnel and required Level 2 Clinical Competency re-trainings as needed.
• Responsible for assessing delegated competencies and communicating with Clinical Training Supervisor of readiness of staff.
• Assist the Clinical Training Supervisor with the validation activities of clinical equipment and procurement of study specific equipment as applicable per study protocol requirements.
• Clinical procedures as applicable under scope of practice for Certified Medical Assistant
• Identify opportunities for change and assist Clinical Training Supervisor and Clinical Leads with implementation of process change.
• Perform ad-hoc duties as required to support ongoing operations.

The Candidate

• Minimum qualifications – Certified Medical Assistant

• Minimum 2 years work experience within a Clinical research environment preferred

• Experience in training colleagues on clinical procedures and processes

• 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 (e.g. Excel, Word, PowerPoint)

• Excellent verbal, non-verbal and written communication skills.

• Excellent interpersonal and customer service skills.