Crcii

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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