Clinical Research Assistant
Benaroya Research Institute
Summary
The Clinical Research Assistant supports clinical research activities within the Clinical Research Program at Benaroya Research Institute (BRI). Working closely with Clinical Research Coordinators, investigators, and clinical staff, the Clinical Research Assistant assists with the conduct of clinical research studies and helps ensure that study activities are performed accurately, efficiently, and in accordance with study protocols and applicable regulations.
Job description
The Clinical Research Assistant may support research conducted at BRI, as well as studies involving affiliate or collaborating research sites. Responsibilities may include study start-up and preparation, participant screening and recruitment, informed consent, clinical data collection, participant care coordination, regulatory documentation, test article handling, specimen collection and processing, and maintenance of accurate source documentation and case report forms. This position is an excellent opportunity for an individual interested in developing a career in clinical research while gaining hands-on experience with clinical trial operations, participant interaction, and research processes.
Clinical Research Support
- Support Clinical Research Coordinators with study activities.
- Assist with study start-up and preparation.
- Support participant screening, recruitment, and scheduling.
- Assist with informed consent activities.
- Collect participant history and protocol-required information.
- Document adverse events and concomitant medications.
- Support protocol-required participant visits and assessments.
- Obtain vital signs and perform basic health assessments.
- Conduct telephone screening and triage as appropriate.
- Coordinate participant appointments, treatments, and follow-up.
- Communicate professionally with participants and research staff.
Research Data and Documentation
- Maintain accurate source documentation and study records.
- Assist with case report form completion.
- Enter and maintain clinical research data.
- File and maintain regulatory documents.
- Assist with preparation for monitoring visits and audits.
- Identify and escalate protocol or data issues.
- Support appropriate research and standard billing.
- Maintain participant and study confidentiality.
Specimen and Test Article Support
- Collect, process, label, and store research specimens.
- Perform phlebotomy as permitted by licensure and training.
- Handle test articles according to study requirements.
- Follow universal precautions and safety procedures.
Compliance and Quality
- Follow study protocols and institutional procedures.
- Comply with FDA, GCP, ICH, HIPAA, and IRB requirements.
- Support participant safety and study quality.
- Maintain required training and competencies.
- Participate in quality and process improvement activities.
- Perform other duties as assigned.
Requirements
- Knowledge of medical terminology and basic patient care.
- Strong organizational and attention-to-detail skills.
- Ability to follow protocols and procedures.
- Effective written and verbal communication skills.
- Ability to work collaboratively in a multidisciplinary team.
- Commitment to participant safety and research quality.
- Medical Assistant, Phlebotomist, and Medical Assistant–Registered licenses, or ability to obtain licensure after hire.
- Healthcare or vocational training in a related field.
- Experience in healthcare, clinical research, or patient care.
- Knowledge of clinical research practices and terminology.
- Familiarity with FDA, GCP, ICH, HIPAA, and IRB requirements.
- Experience with vital signs, phlebotomy, or specimen processing.
- Experience with electronic medical records or research databases.
- Interest in pursuing a career in clinical research.
Benefits
- Medical, Dental & Vision
- Flexible Spending Accounts
- Short & Long-Term Disability
- Life & AD&D Insurance
- 403(b) Retirement Plan
- Paid Time Off
- Employee Assistance Program
- Educational Assistance Program
- Subsidized ORCA Pass
- Wellness Benefits
- Voluntary Benefits
Company overview
Benaroya Research Institute (BRI) is a premier non-profit biomedical research organization founded in 1956 and based in Seattle, Washington. As an affiliate of Virginia Mason Health System, BRI specializes in cutting-edge research focused on the immune system and autoimmune diseases. The institute conducts comprehensive basic, clinical, and translational research aimed at understanding immune cell function and dysfunction, with particular emphasis on conditions such as type 1 diabetes, rheumatoid arthritis, multiple sclerosis, lupus, and allergies. BRI maintains extensive biorepositories containing over 350,000 samples from more than 16,000 participants, supporting both internal research and global scientific collaborations. The institute has made groundbreaking contributions including the development of MHC Class II tetramers for immune cell research, discovery of the Th2A allergy cell, and playing a key role in the development of teplizumab - the first drug to delay the onset of type 1 diabetes. With a mission to predict, prevent, reverse, and cure immune system diseases, BRI operates through multiple core laboratories and leads major research consortia including the Immune Tolerance Network, positioning itself as a global leader in immunology research and therapeutic development.