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.
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At Orca Bio, we are on a mission to transform the lives of patients battling blood cancer through innovative cell therapies. We believe in creating a supportive and dynamic environment, and that's why we're looking for a proactive Clinical Trial Assistant (CTA) to join our talented team. In this role, you'll be at the heart of our clinical trial operations, working closely with our passionate clinical research teams to ensure that the research sites are well-prepared for visits, data is of the highest quality, and communication flows smoothly. As a CTA, your day-to-day responsibilities will include assisting site CRAs in site visit preparations and maintaining meticulous data entry while tracking progress. You'll also be responsible for updating our clinical trial management system (CTMS) with essential details following site visits. Your proactive follow-up on action items and meticulous management of documents will play a crucial role in our trials' success. We value an organized and detail-oriented approach, and if you have experience in a clinical trial support role, or are eager to take your first steps into this field, we’d love to hear from you. At Orca Bio, you won’t just be another employee; you’ll be part of a passionate community that's committed to reshaping how patients receive care while living our core values of passion, courage, and integrity every day. If you’re ready to embrace the challenge and contribute to groundbreaking research in hematology and oncology, we encourage you to apply and be part of our mission to enhance the lives of patients worldwide.
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