Conduct clinical audits and risk assessments to identify compliance gaps.
Manage multiple client engagements and deliver accurate project results.
Build strong client relationships and present findings to leadership.
Kodiak Solutions transforms healthcare through technology-driven solutions, specializing in finance, unclaimed property, and risk management. Their innovative platform streamlines operations, allowing providers to focus on patient care.
Conduct regulatory audits of COG institutions for compliance with NCI CTMB guidelines, IRB submissions, and informed consent documents.
Review protocol deviation forms and early closure requests, ensuring alignment with COG policies and federal regulations.
Serve as primary regulatory contact for sites, respond to complex inquiries, and develop SOPs and guidance documents.
COG Research Foundation, LLC is a California 501(c)(3) entity founded in 2024 to serve as a fiscal sponsor for the Children's Oncology Group (COG), providing legal, fiduciary, and administrative oversight for childhood cancer research. The organization unites over 13,500 experts at more than 220 leading hospitals and cancer centers worldwide, fostering a collaborative and mission-driven culture focused on improving outcomes for children with cancer.
Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory requirements.
Review electronic medical records and source documentation for accuracy and data integrity.
Support site staff and contribute to development of trial materials, SOPs, and training guides.
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve transplant outcomes for blood cancer patients. The company maintains a start-up culture with an entrepreneurial spirit and emphasis on camaraderie.
Support Clinical Trial Managers with study start-up, protocol development, and Trial Master File preparation.
Coordinate with clinical sites on documentation, training, and compliance with FDA and GCP requirements.
Assist with tracking study payments and providing operational support across the full study lifecycle.
The company is a partner organization specializing in clinical research and development, operating through Jobgether. It offers a structured clinical operations environment with cross-functional teams and professional growth opportunities.
Support the development and execution of clinical regulatory strategies for assigned programs across regions.
Prepare and manage IND applications and other regulatory submissions, ensuring accuracy and timely delivery.
Provide regulatory guidance to cross-functional teams and participate in health authority interactions.
Zai Lab is an innovative, research-based biopharmaceutical company based in China and the US, focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients worldwide. Founded in 2014, Zai Lab has a global team of approximately 2000 employees and is committed to gender diversity and environmental responsibility.