CRCII

Work Schedule

Environmental Conditions

Job Description

Essential Functions:

• Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines. 
• Provides medical care to patients, always ensuring patient safety comes first. 
• Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized. 
• Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG's, etc.). 
• Records all patient information and results from tests as per protocol on required forms. 
• Where required, may complete IP accountability logs and associated information. 
• Reports suspected non-compliance to relevant site staff. 
• Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study. 
• Promotes the company and builds a positive relationship with patients to ensure retention. 
• Attends site initiation meetings and all other relevant meetings to receive training on protocol. 
• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
• Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe. 
• Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded. 
• Adheres to company COP/SCOP. 
• May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility. 

Knowledge, Skills & Abilities:

• Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.) 
• Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving 
• Demonstrated ability to exercise discretion and sound judgement 
• Good decision-making, negotiation and influencing skills 
• Good communication skills and English fluency will be an advantage 
• Good organizational skills 
• Good proficiency in basic computer applications 
• Good interpersonal skills to work in a team environment