Clinical Research Coordinator I (Temporary/Part-Time) at INBIOS INTERNATIONAL INC

Seattle, Washington, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Aug, 26

Salary

31.25

Posted On

12 May, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Site Monitoring, Regulatory Binder Maintenance, IRB Submissions, Electronic Data Capture, Clinical Protocol Compliance, Site Initiation Training, Product Registration, IVDR Compliance, GCP Guidelines, Technical File Preparation, Written Communication, Verbal Communication, MS Office, Electronic Database Systems, Project Management

Industry

Biotechnology Research

Description

Description 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. About Us 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. Location: Seattle, WA Type: Part-Time (30 hours per week), Temporary (6-months) | Hybrid 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. Position Wage Range: $26.44 – $31.25/per hour What You’ll Do 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. Key Responsibilities Clinical Site Monitoring Under the direction of the Project Manager 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. Product Registrations (International) 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. What We’re Looking For Required 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. Preferred 1- to 3-year experience in project management. Certified Clinical Research Associate credential. Perks & 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 Apply Today Be part of a team that’s advancing science and improving lives.

Responsibilities

Support clinical studies through site monitoring, regulatory binder maintenance, and ensuring participant compliance with protocols. Assist in international product registrations by identifying regulatory requirements and preparing technical files in compliance with IVDR.