Clinical Research Assistant

Clinical Research Assistant

The Research Assistant position is responsible for all research-related lab duties, such as collecting and shipping biological samples, and for providing administrative research support and direct patient care activities while following strict protocols and directives from leadership.

Essential Functions

Protocol and Regulatory Compliance

• Ensure that procedures are conducted according to each individual IRB-approved clinical trial protocol; sponsor instructions; established company policies and procedures; applicable state and federal regulations; Good Clinical Practices (GCPs); and ICH/FDA guidance documents.
• Acknowledge and sign regulatory documents in accordance with applicable timelines and study requirements.
• File and maintain appropriate documentation associated with assigned clinical studies, including investigational product storage and accountability.

Patient Recruitment & Enrollment Execution

• Identify, screen, schedule, and enroll eligible participants into IRB-approved clinical trials in a timely and compliant manner.
• Explain study protocols and requirements clearly to prospective participants and obtain informed consent following ethical and regulatory standards.
• Carry out delegated duties ensuring adherence to the study schedule to support enrollment goals and minimize dropout rates. 
• Participate in site recruitment efforts.

Clinical & Patient Care Proficiency

• Draw, prepare, process, and package blood and other biological specimens according to study protocols and IATA shipping regulations.
• Record and maintain temperature logs to ensure specimen integrity and equipment compliance.
• Perform or assist with direct patient care activities as delegated, including:
  • Informed consent process
  • Physical assessments and medical history intake
  • Vital signs measurement (BP, pulse, temperature, respiration, height, weight)
  • Blood draws and handling of biological specimens
  • FibroScans and ECGs 
  • Identify potential abnormalities in 6 standard vital signs and escalate findings appropriately.

Data Integrity and Documentation Accuracy

• Ensure that study data is complete, accurate, and entered promptly into the sponsor’s Electronic Data Capture (EDC) system according to protocol timelines and expectations.
• Create and maintain up-to-date and compliant source documentation (paper-based and/or electronic) for each study participant visit and study-related task.

Communication and Team Collaboration

• Maintain effective and ongoing communication with sponsor(s), research staff, ObjectiveHealth team members, and investigators.
• Maintain the ability to multi-task while supporting multiple members of the Clinical Research team, including peers, supervisors, and Investigators (PIs and Sub-Is).
• Attend all research site, company, and study-team meetings, and participate in strategic planning as needed.
• Report on the status of trials, as requested.

Quality Assurance and Audit Readiness

• Oversee Quality Control (QC) activities for the lab to ensure protocol compliance and data integrity.
• Participate in both internal company audits and external sponsor audits, ensuring that all findings are addressed with appropriate corrective and preventive actions (CAPAs).

Study Coordination and Visit Management

• Maintain inventory of lab supplies, dry ice, and lab kits; place orders as needed to ensure consistent and uninterrupted study workflows.
• Execute the Research Center’s monthly visit goals by managing patient scheduling and visit compliance.
• Monitor participant progress, protocol adherence, and data collection throughout the study lifecycle.
• Track all study-related activities for monthly invoicing, and ensure supporting documentation is maintained.
• Provide real-time updates to stakeholders on study status and visit metrics.

Study Initiation and Close-Out Activities

• Participate in Site Initiation Visits (SIVs), study start-up activities, and study close-out procedures.
• Attend Investigator Meetings and other sponsor-mandated training sessions, which may include occasional out-of-town travel.

Incident and Deviation Reporting

• Collect and report Adverse Events (AE), Serious Adverse Events (SAE), and protocol deviations during patient visits.

Professionalism and Organizational Citizenship

• Act as a professional, respectful, and dependable team member in alignment with company values and mission.
• Serve as a strong advocate for the organization’s initiatives, values, mission, culture, and service to clinical research participants.
• Demonstrate adaptability and a proactive mindset in strategic planning and continuous improvement efforts.
• Additional duties as assigned.