Clinical Research Associate
Posted on Monday, September 25, 2023
Over one million people in the world today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many patients, the transplant itself can prove fatal or lead to serious conditions, such as graft versus host disease.
Orca Bio's investigational, high-precision cell therapies are designed to replace a patient's compromised blood and immune system with a healthy one, while dramatically lowering the risk of developing life-threatening or debilitating transplant-related side-effects. The first application of Orca Bio’s platform is in blood cancer where the unmet need is most acute; with a robust pipeline of promising cell therapies, we plan to extend into autoimmune diseases and genetic blood disorders as well.
This CRA position can be hired as a contractor or full-time employee and can be based anywhere in the U.S., although west coast is preferred because that is where the majority of the trial sites are located. Travel expected: ~1+ site visit per week, for sites that do not permit virtual monitoring.
In this 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.
- 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
- BA/BS or equivalent with a minimum of 2 years of relevant clinical trial management experience
- 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, in a co-monitoring capacity
- 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
- 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
- Ability to work 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
Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all patients who need them.
We strive to do things right, and to embody our core values of passion, courage, and integrity. Excellence in our work means the potential to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate daily on a path that hasn’t been paved. This means we lean heavily on our entrepreneurial spirit and are comfortable taking calculated risks to achieve progress toward our mission. It means we aren’t afraid to ask “why not,” and encourage lively discourse around rethinking the status quo.
We work hard to preserve our start-up culture rooted in camaraderie and leadership by example - by everyone, regardless of title.
We’re proud to be an equal opportunity employer, and have seen how our differences - when celebrated and woven together - create stronger and more lasting solutions that better serve our team, our partners, and most importantly, our patients and the providers who treat them.
Notice to staffing firms
Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent department, and all candidates are presented through this channel only. We do not accept unsolicited resumes.