Clinical Research Associate I

Just-Evotec Biologics•Seattle, WA

1d•Remote

About The Position

At Just-Evotec, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what’s possible. We're on a mission to create a place where curiosity isn't just encouraged, it’s celebrated. Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you! The Role: We’re looking for a passionate and curious, CRA 1 to join our team. If you’re excited by new challenges, to work as the lone CRA in a small clinical development group, you might just be the perfect fit. In this role, you’ll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. As the CRA 1 at Just-Evotec, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It’s a role where your curiosity will fuel both your personal growth and the success of the team.

Requirements

At least 3 years work experience as a Clinical Trial Assistant or CRA
Understanding of medical and pharmacological terminology
Knowledge of Good Clinical Practice (GCP) guidelines
Strong organizational and planning skills.
Good communication and interpersonal skills
Experience working with CROs

Nice To Haves

Project management experience a plus
Experience maintaining eTMF preferred
Proficient with MS Project and/or Smartsheet preferred
Experience managing clinical lab samples a plus
Data review experience plus
BSc degree in life sciences or related field preferred

Responsibilities

Assist with project management tasks within Clinical Development group
Collaborate with CRO(s) in the execution of clinical trials
Schedule meetings, set agendas, track action items and capture meeting minutes
Prepare, handle, distribute, file, and archive clinical documentation and reports
Monitor and QC the eTMF
Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
Coordinate and manage logistical aspects of clinical trials, such as shipment of lab samples
Help monitor the progress of clinical trials, track timelines and ensure adherence to protocol and other study documentation
Assist in the preparation of regulatory submissions
May review and approve invoices, purchase orders and site payments
Identify and address potential risks to the project timeline, quality, or budget and escalate when necessary
Help manage relationships with external vendors, including CROs, laboratories, and other service providers
Help ensure all study materials are properly archived following the completion of a trial