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