More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
Summary of Role: In this Clinical Research Associate role, you will be responsible for monitoring the progress of clinical studies, either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
We are recruiting for two roles: one based on the West Coast and one based on the East Coast. Travel expected: ~1+ site visit per week, for sites that do not permit virtual monitoring.
Responsibilities:
May serve as the primary monitor and main point of contact for assigned clinical sites
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, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements
Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol
Provide support to site staff including research coordinators and physicians
Assist in the development of trial materials as needed (e.g., case report forms, monitoring guidelines, site tools and training guides)
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
Qualifications:
BA/BS or equivalent with a minimum of 2+ years of CRA experience (for CRA role) or 5+ years with lead monitor responsibilities (Senior CRA)
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
Personal Qualities:
Highly detail oriented with special attention to quality and quality control
Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize
Well organized and able to work under tight deadlines
Demonstrated strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment
Strong interpersonal skills, including verbal and written communication, are essential
Ability to work in a collegial and collaborative manner; independently and as part of a team
Ability to work in a fast-paced and informal startup environment
Highly tolerant and respectful of all members of our team
Strong problem-solving skills with desire to improve upon established processes
Sense of humor
