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 late-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 investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. Orca Bio is seeking an organized and proactive Clinical Trial Assistant (CTA) to support our clinical trial operations. This role will involve working closely with clinical research teams to ensure sites are prepared for visits, maintain data quality, and facilitate effective communication and follow-up on action items. The ideal candidate will collaborate cross-functionally with clinical operations and data management teams and ensure seamless post-visit updates in our clinical trial management systems (CTMS).
Key Responsibilities:
Site Support & Data Quality:
- Assist site CRAs in preparing for site visits and ensure sites are ready for monitoring.
- Support sites in maintaining high-quality data entry and tracking progress.
- Collaborate with data management to identify key areas of focus for sites and CRAs.
System Updates:
- Update CTMS and other relevant systems post-site visits, logging necessary data, including deviations and visit details.
- Ensure accurate and timely updates to all relevant trial documentation.
Follow-up & Action Items:
- Conduct follow-up on action items from site visits to ensure timely resolution and completion.
- Manage site management calls, generate minutes, and provide updates on outstanding items.
- Assist in compiling baseline information for progress reports.
Administrative Support:
- Maintain and update various clinical trial systems, databases, study trackers, and documentation.
- Support the set up and maintenance of the trial master file (TMF).
- Assist with the preparation and submission of clinical trial-related materials as needed.
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.
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.
