Research Assistant in Montclair, California at American Clinical Research Services Opco LLC

Overview: 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.

Position Summary: 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.

Duties and 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

Qualifications:

• 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.
• Certificates, licenses and registrations required:
  • Current, active Medical Assistant (MA) certification required
  • Current CPR/BLS certification required
  • ACRP or SOCRA certification (preferred)
• · Systems & Technology skills 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
• · Other skills required:
  • Fluency in Spanish is preferred.
  • 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

Physical Requirements and/or environmental factors:

• Continually required to stand.
• Continually required to walk.
• Frequently required to sit.
• Continually required to utilize hand and finger dexterity.
• Occasionally required to climb, balance, bend, stoop, kneel or crawl.
• Continually required to talk or hear.
• Continually exposed to bloodborne and airborne pathogens or infectious materials.
• While performing the duties of this job, the noise level in the work environment is usually moderate
• The employee must
  • Occasionally lift and/or move up to 20 pounds.
• Specific vision abilities required by this job include:
  • Close vision
  • Distance vision
  • Color vision
  • Peripheral vision
  • Depth perception
  • Ability to adjust focus
• This position operates in a clinical research and office setting. The role involves interaction with study participants, healthcare professionals, and research staff. Work may include use of electronic systems and medical equipment, as well as occasional travel to clinical sites or meetings.

Equal Opportunity: Empathx is committed to fostering a diverse, inclusive, and equitable workplace where all employees and applicants are treated with respect and dignity. We are proud to be an Equal Opportunity Employer and consider all qualified applicants without regard to race, color, religion, sex, gender identity or expression, sexual orientation, marital status, national origin, ancestry, age, disability, genetic information, veteran status, or any other protected characteristic under applicable law.