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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. 

Accelerated Enrollment Solutions (AES) helps biopharmaceutical companies overcome patient enrollment and research site challenges by combining a powerful patient recruiting solution with more than 150 clinical research sites located throughout the world.  AES is now part of PPD, PPD was acquired by Thermo Fisher Scientific in December of 2021. 

NOTE: this position is full-time office-based in Evansville, IN. (no relocation assistance is provided for this position)

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.

•May provide support in the Pharmacy in all areas of drug administration. Assists with deliveries, checking stock and monitoring inventory of the dispensary. Assists with collating files, counting IP returns and ensuring compliance to company SOPs and COPs.

•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.

Qualifications:

Education and Experience:

•High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

•Technical positions may require a certificate

•Medical Assistant and/or Phlebotomy experience is preferred.

•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.