Clinical Research Assistant at Eximia Research Jupiter, FL

Job Description

Qualifications

• •High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry
• •Phlebotomy if applicable and required by state law
• •Intramuscular dose administration and preparation if applicable and required by state law
• •Demonstrated knowledge of medical terminology
• •Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone
• •Understanding of verbal, written, and organizational skills
• •Demonstrated ability to work as a team player
• •Demonstrated ability to read, write, and speak English
• •Demonstrated ability to multi-task
• •Demonstrated ability to follow written guidelines
• •Demonstrated ability to be flexible/adapt as daily schedule may change rapidly
• •Sit or stand for long periods of time
• •Communicate in person and by a telephone
• •Limited to moderate walking required
• •Limited to lifting up to 30 pounds

Benefits

Responsibilities

• •The Clinical Research Assistant assists the Clinical Operations Team at our Encino, CA location in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities
• •Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Eximia Clinical Network’s SOPs
• •Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations
• •With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations
• •Perform and/or verify equipment calibration and maintenance
• •Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable
• •Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial
• •Enter source data into the sponsor's and/or vendor’s data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator
• •Effectively communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team
• •Understand good documentation in accordance with ALCOA-C principles when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator
• •Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects
• •Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial
• •Understand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in person
• •Maintain confidentiality of patient protected health information, sponsor confidential information and Eximia Clinical Network confidential information
• •Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team
• •Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed
• •Prepare source document charts, copy and/or file medical records and study related documents as required
• •Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems
• •Other duties as assigned