Set up, maintain, reconcile, and archive electronic and paper Trial Master Files
Track study status, enrollment, regulatory documentation, laboratory samples, and site start-up status for assigned clinical projects
Actively order and maintain ancillary clinical study supplies required for the conduct of clinical studies
Vedanta Biosciences is a late-stage biopharmaceutical company developing medicines for the treatment of gastrointestinal diseases. The company’s pipeline has been built using the company’s industry-leading product engine for the development of therapies based on defined consortia of bacteria grown from pure clonal cell banks.
Develops/maintains project timeline inclusive of startup through completion.
Drives development, approval, and distribution of study-related documents and study tools.
Manages distribution, collection and tracking of regulatory documentation.
Penumbra, Inc. is a global healthcare company focused on innovative therapies. They design, develop, manufacture, and markets novel products and has a broad portfolio that addresses challenging medical conditions.
Partner with Clinical Operations leadership to support clinical trial execution.
Lead site feasibility, selection, initiation, and greenlight activities for clinical trial sites.
Provide guidance and oversight to CRAs, including trip report review and training support.
Immatics is dedicated to making a significant difference in the lives of cancer patients. They are a global frontrunner in precision targeting of PRAME, found in over 50 cancers, with cutting-edge science and a strong clinical pipeline.
Monitor the progress of clinical studies at investigative sites or remotely, ensuring trials are conducted per protocol, SOPs, and regulatory requirements.
Conduct monitoring visits, review source documentation, verify data, and ensure accurate reporting of adverse events and protocol deviations.
Develop trial materials, contribute to SOPs, and maintain high-quality monitoring documentation and reports in required timelines.
Orca Bio is a late-stage biotechnology company developing next-generation purified cell therapies to redefine the transplant process for blood cancer patients. The company fosters a fast-paced, collaborative, and entrepreneurial start-up culture with a passionate team driven by core values and a mission to improve patient lives.
We welcome professionals from a variety of backgrounds and experience levels within clinical research.
We look for those passionate about Clinical Operations, Site Enablement & Site Management, and Clinical Business Development Functions.
We also welcome professionals from Regulatory & Compliance, Feasibility & Patient Recruitment, and Patient Access & Healthcare Innovation.
Milestone One's mission is to bring clinical trials to a much broader range of sites and patients around the world. It is a fast-growing global startup operating in an international, multicultural environment that is always looking to connect with talented professionals who are excited to grow with us and contribute to its mission.
Lead a hematology program, overseeing all operational activities and strategic planning.
Provide leadership over CROs and vendors, ensuring timelines, quality, and budget expectations are met.
Collaborate with internal functional leads to drive integrated study execution, providing strategic direction.
Caribou Biosciences is a clinical-stage biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases using CRISPR genome-editing technology. They have a CAR-T cell therapy platform and headquarters in Berkeley, California.
Develop, mentor, manage and coach SSU personnel to ensure quality standards.
Ensure SSU personnel work to the highest quality standards and maintain compliance.
Participate in the interview process for new SSU personnel by conducting CV review.
Precision for Medicine is a Clinical Research Organization with an integrated offering enabling the science of precision medicine. They combine clinical trial designs, operational and medical experts, biomarker and data analytics solutions, with a passion for rare diseases and oncology.
Plan, lead, and manage clinical trials, developing comprehensive project plans for timelines, budgets, and deliverables.
Ensure regulatory compliance by working with the Compliance Team and preparing for audits, adhering to GCP guidelines and company SOPs.
Serve as a primary communication point for sponsors and internal teams, providing regular updates and building client relationships for future business.
Paradigm Health is a company rebuilding the clinical research ecosystem by enabling equitable patient access to trials and enhancing trial efficiency. The team, backed by leading investors like ARCH Venture Partners, is multidisciplinary and committed to creating equitable access to clinical trials for any patient, anywhere.
Lead end-to-end Clinical Data Management activities for assigned clinical studies.
Ensure clinical data are accurate, complete, consistent, and inspection-ready.
Drive proactive risk identification, issue escalation, and resolution across study teams and vendors.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. They are committed to transforming the future of treatment for autoimmune disease, guided by core values and focused on innovation.
Provide operational oversight and support for multiple clinical research sites within the network.
Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, and sponsor protocols.
Build and maintain strong working relationships with Sponsors, CROs, and external partners.
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. They leverage convenient, trusted healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs.
Lead day-to-day data management activities for assigned clinical trials.
Oversee CRO and vendor data management deliverables to ensure timelines, quality, and compliance.
Ensure data integrity, consistency, and completeness through ongoing data review and cleaning.
Faeth Therapeutics is a clinical-stage oncology company advancing PIKTOR, a multi-node PI3K/AKT/mTOR inhibitor program. They are a small, focused team where every person has direct impact and are united by a shared commitment to care deeply, create boldly, and never stop learning.
Perform audits and quality control checks on study calendar builds and financial data entry.
Interpret complex clinical trial protocols into actionable electronic study calendars within the OnCore CTMS.
Build, configure, and maintain study calendars and financials.
City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the U.S.
Contribute to the design of early/late-stage protocols across multiple therapeutic areas.
Develop and write statistical analysis plans, and perform statistical analyses for interim and final reports.
Support submission activities, including design, analysis and reporting of integrated summaries for safety and efficacy.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 4,000 professionals in more than 20 countries, they focus on quality, professional development, and a supportive culture.
Supports all phases of clinical development and execution.
Ensures high quality data by being the study protocol expert and key site resource for questions.
Maintains and tracks clinical study data and supports investigator qualification selection.
SI-BONE is a medical device company focused on minimally invasive sacropelvic solutions. They aim to help patients with sacroiliac pelvic conditions and have provided over 90,000 procedures to date using their iFuse Implant System.