Job Description

Clinical Research Assistant

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.

Role & 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

Qualifications

Education/Experience:

• High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry

Required Licenses/Certifications:

• Phlebotomy if applicable and required by state law
• Intramuscular dose administration and preparation if applicable and required by state law

Required Skills:

• 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

Required Physical Abilities:

• 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

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