Research Assistant

American Clinical Research Services Opco LLCMontclair, CA
$22 - $26Hybrid

About The Position

At Empathx, we drive equitable access to complex trials at any phase by providing industry-leading patient access, clinical trial management, and analysis across cardiology/nephrology, psychiatry/neurology, metabolic, and infectious disease studies throughout the therapeutic pipeline. The Research Assistant (RA) provides hands-on clinical and administrative support to the site's clinical trial team. Working under the direction of the CRC and/or PI, the RA preps and rooms participants, performs delegated MA-level clinical tasks (vital signs, phlebotomy, ECGs, point-of-care testing), and collects, processes, and ships lab specimens per protocol. The RA also supports recruitment and scheduling, completes accurate source documentation, and enters data into EDC systems, escalating any protocol deviations or safety concerns to the CRC/PI. This role requires an active MA certification, prior clinical research experience, and hands-on lab experience.

Requirements

  • High school diploma or general education degree (GED), or one to three months related experience and/or training, or equivalent combination of education and experience.
  • Minimum of 1 year of prior clinical research experience required (e.g., as a Research Assistant, Clinical Research Coordinator support staff, or equivalent role in a clinical trial setting).
  • Prior hands-on laboratory experience required, including specimen collection, processing, and handling.
  • Current, active Medical Assistant (MA) certification required
  • Current CPR/BLS certification required
  • Spreadsheet Software (Excel);
  • Inventory Software;
  • Word Processing Software (Word);
  • Electronic Mail Software (Outlook);
  • Presentation software (PowerPoint);
  • Experience with EDC systems (e.g., Medidata Rave, REDCap)
  • Experience with CTMS and/or eRegulatory/eTMF platforms (e.g., Veeva)
  • Experience with EMR/EHR systems
  • Strong attention to detail and accuracy
  • Ability to manage multiple tasks and priorities
  • Strong organizational and time management skills
  • Ability to work independently and as part of a team
  • Effective communication and interpersonal skills
  • Ability to maintain confidentiality and professionalism
  • Strong problem-solving and critical thinking skills
  • Ability to adapt to changing priorities
  • Ability to exercise sound judgment and decision-making
  • Customer service mindset with focus on patient experience
  • Ability to follow protocols, SOPs, and regulatory requirements
  • Ability to handle high-pressure or fast-paced environments

Nice To Haves

  • ACRP or SOCRA certification (preferred)
  • Fluency in Spanish is preferred.

Responsibilities

  • Perform clinical and laboratory tasks within the scope of MA certification and the site delegation of authority log, including vital signs, phlebotomy, specimen processing, ECGs, and point-of-care testing
  • Prepare, label, process, package, and ship laboratory specimens according to protocol-specific lab manuals, sponsor requirements, and chain-of-custody procedures
  • Maintain proper specimen storage conditions (refrigeration, freezer logs, temperature monitoring) and document deviations promptly
  • Assist with subject recruitment, screening logistics, scheduling, and reminder calls; maintain subject visit calendars
  • Complete source documentation accurately and contemporaneously in compliance with GCP and sponsor requirements
  • Assist with data entry into electronic data capture (EDC) systems and resolve queries under CRC oversight
  • Prepare exam rooms, equipment, and supplies for subject visits; perform equipment calibration checks and maintenance logs
  • Support investigational product (IP) accountability tasks, such as inventory counts and storage temperature logs, as delegated
  • Identify and escalate protocol deviations, adverse events, or safety concerns to the CRC/PI immediately upon observation
  • Adhere to OSHA, CLIA, and site infection control/bloodborne pathogen standards when performing clinical and laboratory duties
  • Support audit and inspection readiness, including participation in sponsor audits, regulatory inspections, and internal quality reviews
  • Complete all required SOP training and company-required trainings as assigned and when updated
  • Maintain all required licenses and certifications and ensure they remain current and in good standing
  • Travel to company meetings, site locations, or study-related activities as required
  • Perform other duties as assigned
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