Job Description

　　At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

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　　Location/Division Specific Information

　　Cincinnati, Ohio

　　Discover Impactful Work:

　　A day in the Life:

　　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 substantial 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 introduced 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 0

　　to 1 year).

　　Knowledge, Skills and Abilities:

　　• Basic understanding of Good Clinical Practices (GCP), with ability to learn and maintain a good

　　working knowledge of FDA regulations and company/client SOPs and SOPs

　　• Good organizational skills and flexibility to manage workload and meet changing timelines, handling

　　multiple tasks efficiently and effectively

　　• Good attention to detail to ensure accuracy and efficiency in data entry

　　• Good interpersonal/customer service skills, positive attitude and good oral and written

　　communication

　　• Capable of working in a team or independently

　　• Good English language and grammar skills written and verbal

　　• Good computer skills, including proficiency in MS Office (Word, Excel, and PowerPoint) and capable

　　of learning new clinical trial database systems

　　• 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.

　　Accelerated Enrollment Solutions is a business unit of Pharmaceutical Product Development, LLC, a Delaware limited liability company ("PPD"),

　　collectively made up of Acurian, Inc. and Synexus, each a subsidiary of PPD.

　　• 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%