Summary:In this Senior CRA role, you will be responsible for monitoring the progress of both our early and late phase clinical studies (primarily, our phase 3 Precision-T study), 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. You can be based anywhere in the U.S. Travel expected: ~1+ site visit per week, for sites that do not permit virtual monitoring.
Responsibilities:
- 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
Desired Qualifications:
- BA/BS or equivalent with a minimum of 5+ 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 leading and 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
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, particularly with healthcare professionals and clinical site staff
- 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
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 who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.
To learn more: https://orcabio.com/join-our-team/
**all official communication will be from @orcabio.com; please beware of scams**
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 team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.
United States
