Research Assistant

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
• Absorb and enter data 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

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; Strong organizational and time management skills; Ability to manage multiple tasks and priorities; 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