RESEARCH ASSOCIATE - AES

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.

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 and Other Job Information:

• 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 medicalfacilities 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.

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 widerange 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.

PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.