CRC I

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Conducts clinical studies according to FDA/GCP and ICH regulations and
guidelines.
Provides medical care to patients, always ensuring patient safety comes first.
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 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.