We are seeking a Clinical Research Associate / Medical Assistant to join our site in Atlanta, GA!
Promote the company and build positive relations with patients to ensure participation and retention.
May perform basic clinical/lab duties or procedures like blood draws, fibroscans, administration of drugs, ECGs, vital signs, centrifuge operation, storing and/or shipping specimen, etc.
Attends initiation meetings when necessary to obtain study process clarification.
Reviews inclusion/exclusion criteria with patients to ensure eligibility to participate in study.
Supports and witnesses the consenting process for participants.
Prepares study-specific documents for pre-study screening.
Assists with the maintenance of a screening/enrollment log and required documentation such as screening failures and phone communications to patients and/or clients.
Ensures the safety of patients by monitoring and assessing AEs, if any, and communicating potentially serious findings to physician.
Contributes to the overall research experience of each patient to assure a positive experience.
Performs other study-related duties as qualified by documented training.
Assists with patient follow-up visits by preparing the files, ensuring all data, forms and results are attached in the files.
May assist in the pharmacy and unpacking IP and taking stock.
May assist with patient interviews to get more information.
May be responsible for the overall site appearance, consumables and disposals (i.e., tidiness of patient areas, availability of consumables in the bathrooms as well as biomedical disposal arrangements).
Fulfills all duties according to protocol, SOP/COP, ICH GCP and local regulations and reports any non-compliance.
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 at least 2+ 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
Demonstrated ability managing multiple responsibilities and completion of projects in either a work or school setting
Basic computer skills including knowledge of Microsoft Office and the ability to learn various programs and/or systems such as the Oracle database
Strong communication skills and capable of clearly explaining information to a wide variety of individuals
Capable of functioning with multiple types of individuals in potentially difficult or uncomfortable settings
Strong attention to detail
Strong planning and organization capabilities to manage multiple tasks and multiple study groups at one time
Effective time-management skills
Strong auditing and documenting skills
Ability and willingness to learn to administer investigational drugs or test investigational devices, to include dosing orally, intravenously, topically or other approved dosing methods
We offer a comprehensive benefits package that includes medical, dental, and vision insurance offerings, life and disability insurance offerings, 401K, paid time off, and various other benefits and discount programs!
We are an Affirmative Action and Equal Opportunity Employer.
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.
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