Clinical Research Coordinator I (Temporary/Part-Time)

INBIOS INTERNATIONAL INC • Seattle, WA

19h • Hybrid

About The Position

Are you a detail-oriented problem-solver with a passion for purpose-driven work? Join InBios, a mission-focused biotech company developing diagnostic tools that combat infectious diseases worldwide. InBios International Inc. has been in business since 1996 designing and manufacturing diagnostic assays for emerging infectious diseases and biothreats. Our work supports global health initiatives and government-funded research, with a strong emphasis on innovation, quality, and compliance. Based in Seattle, we offer a collaborative culture, competitive compensation, and meaningful work that makes a global impact. This is a project-based position funded by a federal contract. If selected for the position, you will be hired as a temporary, part-time employee and the term of employment is dependent upon ongoing funding. We're looking for a temporary, part-time Clinical Research Coordinator to support clinical studies and international product registration. The successful candidate must have a BS in a scientific discipline, have familiarity with Good Clinical Practice (GCP) and have excellent attention to details as well as good communication skills but written and verbal.

Requirements

• Bachelor’s degree in a scientific discipline.
• Strong attention to detail, excellent written and verbal communication, and proficiency with technology (e.g., MS Office, Electronic Database Systems).
• Knowledge of ICH GCP guidelines. GCP certification.
• Entry-level knowledge of IVDR requirements for medical devices.

Nice To Haves

• 1- to 3-year experience in project management.
• Certified Clinical Research Associate credential.

Responsibilities

• Assist in the maintenance of regulatory binders and Institutional Review Board (IRB) submissions.
• Monitor clinical study to ensure that all participant records entered into the electronic data capture system are accurate and follow the clinical protocol and source documents.
• Participate in Site Initiation training (SIV), monitor study compliance, and assist with study closeout.
• Ensure that participants enrolled in the study meet the inclusion/exclusion criteria.
• Monitor and report protocol deviations and adverse events in a timely manner.
• Participate in study site close-out.
• Identify regulatory requirements for product registrations worldwide.
• Review analytical and clinical data against country regulatory requirements and identify gaps that need to be filled to obtain product registration.
• Assist in the preparation of technical files in compliance with IVDR.

Benefits

• Medical, dental, vision, life & disability insurance
• 401(k) + Roth IRA + FSA
• Prorated paid holidays and sick time as applicable to term of employment and work schedule in accordance with policies stated in the Company’s employee handbook.
• Supportive, mission-driven culture

What This Job Offers

• Job Type: Part-time
• Career Level: Entry Level