Clinical Research Assistant

Headlands Research • Portland, OR

7h • Onsite

About The Position

The Clinical Research Assistant is a member of the clinical research team at Summit Research in downtown Portland, Oregon. Working under the supervision of the Site Director, Principal Investigator, and Clinical Research Coordinators (CRCs), the assistant supports daily clinical trial operations, regulatory compliance, study activities, data integrity, and participant care. The position is onsite and scheduled Monday through Friday, 8:00 a.m. to 5:00 p.m. It is a regular, full-time employee role.

Requirements

• Bachelor’s degree preferred, or equivalent experience.
• At least one year of experience in a clinical research or healthcare environment.
• Strong attention to detail and ability to collect, compile, and analyze data accurately.
• Strong interpersonal, verbal, and written communication skills.
• Proficiency in Microsoft Office and Electronic Data Capture (EDC) systems.
• Ability to prioritize tasks, meet deadlines, and work in a fast-paced environment.
• Comfort working independently and as part of a team.
• Basic computer literacy.

Nice To Haves

• Familiarity with medical terminology, laboratory procedures, and research protocols.
• Understanding of HIPAA, FDA, GCP, and ICH guidelines.
• Laboratory skills such as blood draws and specimen processing.
• BLS/CPR, CNA, CMA, or similar certification.

Responsibilities

• Prepare and maintain study documents, including source charts, study binders, regulatory binders, and laboratory kits.
• Schedule and confirm participant appointments, including ancillary visits such as diagnostic imaging and vendor services.
• Follow study protocols, inclusion and exclusion criteria, and regulatory requirements, including FDA, Sponsor, and Good Clinical Practice guidelines.
• Support participant recruitment by prescreening electronic medical records, following up on referrals, and coordinating outreach.
• Explain study procedures to participants, answer questions, and monitor diary compliance.
• Conduct study procedures, including collecting vital signs, performing ECGs, and completing study questionnaires.
• Make follow-up and reminder calls to support participant adherence to visits and protocols.
• Assist with participant stipend tracking and processing.
• Draw blood, process biological samples, and ship samples according to study requirements.
• Maintain laboratory equipment, supplies, and temperature control systems in accordance with study protocols.
• Generate and file weekly laboratory-system temperature reports.
• Enter and verify study data in EDC, CTMS, and other databases.
• Address system-generated queries and perform quality control checks for data accuracy and completeness.
• Assist with case report forms and source document completion, including query resolution under study coordinator guidance.
• Maintain and organize participant charts, Investigator Site Files, and other regulatory documents.
• Support CRCs by filing, scanning, and faxing required documents.
• Clean, stock, and maintain exam rooms and department supplies for participant visits.
• Participate in investigator meetings, study teleconferences, and trainings.
• Assist with onsite or remote clinical research monitor visits.

Benefits

• Health insurance, including medical, dental, and vision.
• Health Savings Accounts (HSA) and Flexible Spending Accounts (FSA).
• Paid Time Off (PTO).
• Disability, accident, and life insurance options.
• 401(k) plan with company match.
• Professional development and career growth opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed