Senior Clinical Research Associate
Orca
full-time
Posted on:
Location Type: Remote
Location: Remote • New York • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Responsible for monitoring the progress of clinical studies at investigative sites or remotely
- Ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, SOPs, ICH-GCP, and regulatory requirements
- Conduct interim monitoring visits and review electronic medical records
- Source documentation verification against case report form data
- Provide support to site staff including research coordinators and physicians
- Assist in the development of trial materials
- Contribute to the development of Clinical Operations SOPs
Requirements
- BA/BS or equivalent with a minimum of 2+ years of CRA experience or 5+ years with lead monitor responsibilities
- 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
Benefits
- Equal opportunity employer
- Passion for science and compassion for patients
- Start-up culture of camaraderie and leadership
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical research associate (CRA)clinical trial monitoringsource documentation verificationtrial materials developmentFDA regulationsICH-GCP guidelinesclinical monitoring proceduresTrial Master File managementelectronic medical records (EMR)electronic data capture (EDC)
Soft skills
communicationteam supportorganizational skillsindependent monitoringleadership