May perform technical procedures running patient clinics including vital signs, Fibroscan, height, weight, Electrocardiogram etc. Fully informs patients about the tests to be conducted and guides patients in the requirements of the trial.
May perform Phlebotomy tests.
Performs non-technical procedures, including urine collection, subject walks and safety monitoring.
Prepares and calibrates equipment for testing to ensure proper functioning.
Interacts regularly with patients during study visits in order to perform study related procedures.
Undertakes screening tests in accordance with protocol requirements.
Assists in the lab, sample processing and/or liaise with laboratories.
Manages and/or completes ordering of clinical supplies.
May assist with or oversee the maintenance of accurate freezer logs, specimen labelling and other documentation.
May take consent if permitted according to country regulations.
Reports Quality Incidents and participates in the investigation and resolution.
Provides administrative support as needed.
Ensures adherence to COP's, SOP's, GCP and local regulations.
Provides training to new staff.
Note: Some tasks listed above only to be conducted as per country regulations and with relevant valid qualifications/ certification or supervision.
Knowledge, Skills and Abilities:
Good medical terminology and ability to perform conducting of vital signs
Strong understanding of Good Clinical Practices (GCP), with ability to learn and maintain a good working knowledge of FDA regulations and company/client SOPs and WPDs
Strong organizational skills and flexibility to manage workload and meet changing timelines, handling multiple tasks efficiently and effectively
Thorough attention to detail to ensure accuracy and efficiency in data entry
Strong interpersonal/customer service skills, positive attitude and good oral and written communication
Capable of working in a team or independently
Strong English language and grammar skills
Strong computer skills, including proficiency in MS Office (Word, Excel, and PowerPoint) and basic understanding of clinical trial database systems
Strong analytical and data management skills to effectively analyze data/systems to ensure accuracy and efficiency
