Job Description



Summarized Purpose:
Provides general support to technical procedures. 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.


Essential Functions
• May perform technical procedures at the site including vital signs, blood
collection, height, weight, electrocardiogram etc. as per local regulations. Fully
informs patients about the tests to be conducted and guides patients in the
requirements of the trial.
• 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.
• Answers incoming telephone calls.
• Assists in the lab and/or liaises with laboratories regarding sample collections
and sample processing.
• Completes clinical supply orders and maintains appropriate levels.
• May collect medical history information for potential patients, liaising with
medical facilities and networks to collect patient files, documentation and other
relevant information as may be required as per protocol.
• Maintains accurate freezer logs, specimen labelling and other documentation when required.
• May take consent if permitted according to country regulation.
• Reports Quality Incidents and supports investigation and resolution.
• Provides administrative support as needed.
• Ensures adherence to COP's, SOP's and GCP and local regulations.
• Note: Some tasks listed above only to be conducted as per country regulations and with relevant valid qualifications/ certification or supervision.


Job Complexity: Works on assignments that are moderately difficult, requiring judgment in resolving issues or in making recommendations.


Job Knowledge: Has meaningful understanding of the job and applies knowledge and skills to complete a wide range of tasks.


Supervision Received: Normally receives little instruction on daily work, general instructions on newly eintroduced assignments.


Business Relationships: Contacts are frequent with individuals representing other departments, and / or representing outside organizations. Contacts involve obtaining or providing information or data on matters of moderate importance to the function, or the department, or which may be of sensitive nature.


Qualifications:


Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 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 interpersonal skills, customer service philosophy and flexibility to handle last minute and
frequent changes to study flowcharts
• Ability to interpret study protocols
• Strong problem-solving and mediation skills to function with multiple types of individuals in potentially
difficult or uncomfortable situations
• Firm organizational and time management skills with the ability to multitask and oversee numerous
studies with a variety of therapeutic areas and sizes simultaneously
• Proficient computer skills (i.e., Microsoft Office and computerized databases such as Oracle)
• Strong data integrity skills and attention to detail
• Good understanding of the clinical research process preferred (GCP, Informed consent, Drug
Dispensing and accountability, data collection)
• Ability to work well in a collaborative team environment


Management Role:
No management responsibility


Working Conditions and Environment:
• Work is performed in an office or clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations. Potential Occasional travel required.


Physical Requirements:
• Frequently stationary for 4-6 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional 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.
• May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
• Works with guidance or reliance on oral or written instructions from management. May require 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.


Percent Billable:
80% - 100%