Clinical Research Associate

Orca

. Responsible for monitoring the progress of clinical studies, either at investigative sites or remotely .

Posted 5/7/2026full-timeRemote • 🇺🇸 United StatesJuniorMid-LevelWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Responsible for monitoring the progress of clinical studies, either at investigative sites or remotely
Ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, SOPs, ICH-GCP, and all applicable regulatory requirements
Conduct interim monitoring visits (IMVs) and ISF review
Review electronic medical records (EMR)/patient data
Source documentation verification (SDV) against case report form data, including informing the site staff of any entry errors and ensuring good documentation practices
Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting
Provide support to site staff including research coordinators and physicians
Assist in the development of trial materials as needed
Contribute to the development of Clinical Operations SOPs, best practices, work instructions, tools and templates
Author and submit high-quality monitoring visit reports within required timelines
Ensure completeness and accuracy of monitoring documentation in the eTMF

Requirements

What you’ll need

BA/BS or equivalent with a minimum of 2+ years of CRA experience (for CRA role) or 5+ years with lead monitor responsibilities (Senior)
Therapeutic experience in oncology/hematology and cell and gene therapy preferred
Prior CRA experience working directly for sponsor, ideally a start-up/or small company, with primary site ownership and independent monitoring responsibility
Strong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
Experience with Trial Master File management according to the DIA reference model
Experience operating within various site EMR/EHR systems
Experience using eTMF, EDC (IBM Zelta experience ideal), CTMS, and other vendors systems/portals, as well as working on trials without a CTMS in place

Benefits

Comp & perks

Competitive medical, dental, and vision benefits
PTO
401(k) plan
Life and accidental death and disability coverage
Parental leave benefits
Subsidized daily lunches and snacks at on-site locations
Pre-IPO equity and annual bonus

ATS Keywords

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Hard Skills & Tools

clinical monitoringsource documentation verificationadverse event reportingtrial materials developmentmonitoring visit report authoringeTMF managementEDCCTMSFDA regulationsICH-GCP guidelines

Soft Skills

communicationorganizationalattention to detailproblem-solvingcollaborationsupportiveindependent monitoring