Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Provides general support to technical procedures with a range of complexity, including phlebotomy.
Collects study-specific data by performing technical and non-technical procedures and interacting with patients. May also assist with the verification of patient data and collecting source documentation to complete the medical history. Monitors and ensures overall compliance at the site.

• 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.

• Under the general supervision of a licensed physician, may conduct the education, evaluation, treatment and follow-up of sleep disorders for clinic patients by following sleep laboratory operating procedures, applying electrodes and sensors to ensure the collection of appropriate data of the sleep testing process.

• 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.

Qualifications:

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2 years).

• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

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

Working Conditions and Environment:

• Work is performed in an office environment with exposure to electrical office equipment.

• Occasional drives to site locations with occasional travel both domestic and international.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Frequent mobility required.

• Occasional crouching, stooping, bending and twisting of upper body and neck.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop

• computer with a maximum lift of 15-20 lbs.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.

• Frequently interacts with others to obtain or relate information to diverse groups.

• Works independently with little guidance or reliance on oral or written instructions and plans work

• schedules to meet goals. Requires multiple periods of intense concentration.

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions

• with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.

• Regular and consistent attendance.