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.
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.
Prepare and manage operating budgets based on performance and revenue.
Identify research costs and develop multi-year budgets for trials.
Monitor invoices and ensure conformance with budgetary limitations.
Fred Hutchinson Cancer Center is a non-profit organization that provides adult cancer treatment and conducts groundbreaking research on cancer and infectious diseases. They are based in Seattle and have a reputation as one of the world’s leading cancer, infectious disease, and biomedical research centers.
Enter clinical trial data into EDC systems accurately and on time per study protocols and sponsor requirements.
Perform routine data quality checks, identify and resolve discrepancies, and support query resolution to keep studies on track.
Track data entry timelines across multiple concurrent studies and support database lock activities with organized, audit-ready documentation.
Profound Research partners with community physicians to offer clinical trials as a therapeutic option for their patients, handling all infrastructure and operations. It is a collaborative organization that invests in professional growth and offers competitive benefits.
Monitor assigned accounts for irregularities, non-payments, and delayed payments.
Contact Sponsors/CROs to follow up on unpaid invoices and ensure timely payments.
Investigate and resolve sponsor, patient and customer disputes, maintaining strong business relationships.
Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, is one of the largest community-based cancer programs advancing oncology treatments and improving outcomes for cancer patients across the globe. SCRI's research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S.
Support Omada’s research program by coordinating day‑to‑day study operations for assigned protocols.
Contact study participants to facilitate timely, complete and accurate participation in study.
Maintain accurate study documentation and trackers so the team has a current view of study status.
Omada Health is reverse engineering the way healthcare is delivered in America, putting the space between doctor visits at the center of care. Omada has served more than two million members since launch across 2,000+ employers and strives to build an inclusive culture.
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.
Serve as the primary operational lead for assigned studies.
Partner with sponsors and CROs as a key point of contact.
Proactively identify operational risks, including enrollment challenges and protocol-related issues.
M3 Wake Research is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations. With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US.
Assist in the coordination and management of clinical trials, including study start-up, maintenance, and close-out activities.
Support Clinical Trial Managers in overseeing CRO deliverables, timelines, issue escalation, and overall study operational performance.
Maintain, organize, and update essential study documentation to ensure they are complete, accurate, and audit-ready at all times.
Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, they've built a global team of over 100 employees headquartered in Boston, with a focus on advancing their lead asset. We encourage people from all backgrounds to apply and cultivate a culture where all voices are included.
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.
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.
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.
Serve as the primary administrator for legal department systems.
Track contract status and follow up with stakeholders to ensure timely completion.
Identify opportunities to improve efficiency and standardize processes.
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 with a focus on Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome.
Develop and negotiate global study budgets based on the requirements of a study protocol.
Review, draft and negotiate a variety of agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements.
Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues.
Precision Medicine Group is a specialized services company supporting life sciences organizations. We don't have information about the company's size, culture or number of employees from the job posting.
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.
Ensures completion and performs functions related to research grants and contracts.
Works with a variety of clients across all Brown University Health affiliates.
Interprets related requirements and regulations and communicates effectively.
Brown University is a leading institution for education, discovery, and global intellectual progress. Founded in 1764, it is also one of the largest employers in Rhode Island, offering an opportunity to contribute to a greater good.
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.