PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.? At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!??
Accelerated Enrollment Solutions (AES) is a business unit of PPD that helps biopharmaceutical companies overcome patient recruitment and research site challenges by optimizing each step in the patient journey to deliver greater speed, certainty, and control to clinical trial delivery.
As a Research Associate you will be a key member impacting the development and research for therapeutics for patients.
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees.??
Provides general support to technicalprocedures. Collects study-specific data by performing technical andnon-technical procedures and interacting with patients. May also assist with the verification of patientdata and collecting source documentation to complete the medical history.
Essential Functionsand Other Job Information:
•May perform technical procedures at the site including vital signs, bloodcollection, height, weight, electrocardiogram etc. as per local regulations. Fullyinforms patients about the tests to be conducted and guides patients in therequirements of the trial.
•Performs non-technical procedures, including urine collection, subject walks andsafety monitoring.
•Under the general supervision of a licensed physician, may conduct theeducation, evaluation, treatment and follow-up of sleep disorders for clinicpatients by following sleep laboratory operating procedures, applying electrodesand sensors to ensure the collection of appropriate data of the sleep testingprocess.
•Prepares and calibrates equipment for testing to ensure proper functioning.
•Interacts regularly with patients during study visits in order to perform studyrelated procedures.
•Undertakes screening tests in accordance with protocol requirements.
•Answers incoming telephone calls.
•Assists in the lab and/or liaises with laboratories regarding sample collectionsand sample processing.
•Completes clinical supply orders and maintains appropriate levels.
•May collect medical history information for potential patients, liaising withmedicalfacilities and networks to collect patient files, documentation and otherrelevant information as may be required as per protocol.
•Maintains accurate freezer logs, specimen labelling and other documentationwhen 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.
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to atleast 4 years).
In some cases anequivalency, consisting of a combination of appropriate education, trainingand/or directly related experience, will be considered sufficient for an individual to meet therequirements of the role.
Knowledge, Skills and Abilities:
•Good medicalterminology and ability to perform conducting of vital signs
•Strong understanding of Good Clinical Practices (GCP), with ability to learn and maintain a goodworking knowledge of FDA regulations and company/client SOPs and WPDs
•Strong interpersonal skills,customer service philosophy and flexibility to handle last minute andfrequent changes to study flowcharts
•Ability to interpret study protocols
•Strong problem-solving and mediation skills to function with multiple types of individuals in potentiallydifficult or uncomfortable situations
•Firm organizational and time management skills with the ability to multitask and oversee numerousstudies 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, DrugDispensing and accountability, data collection)
•Ability to work well in acollaborative team environment
No management responsibility
WorkingConditions 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
•Frequently stationary for 4-6 hours per day.
•Repetitive hand movement of both hands with the ability to make fast, simple, repeated movementsof 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 laptopcomputer 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 toand understand information and ideas presented through spoken words and sentences.
•May interact with others, relating and gathering sensitive information. Interaction includes diversegroups.
•Works with guidance or reliance on oral or written instructions from management. May requireperiods of intense concentration.
•Performs a widerange of variable tasks as dictated by variable demands and changing conditionswith little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
•Regular and consistent attendance.
.As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
Job: *Clinical Research Sites
Organization: *US AES BU
Title: Research Associate / Medical Assistant
Location: FL-The Villages-Compass Research, LLC - The Villages
Requisition ID: 218715
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group