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.
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.
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.
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.
Represent the Biostatistics function for complex studies or at project level.
Independently contribute to design of early/late-stage protocols across multiple therapeutic areas and help draft protocols or amendments.
Develop and write statistical analysis plans and perform statistical analyses for interim and final reports to be submitted to regulatory agencies.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
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.
Prepare and submit regulatory documents to IRBs/ECs and support study start-up activities.
Perform data entry, document cleanup, and QC during migration to Florence eRegulatory.
Maintain CVs, licenses, and GCP documentation, partnering with coordinators, investigators, and sponsors.
UniTriTeam is a global organization that supports clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
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.
Accountable for all core SP deliverables (SDTM, ADAM, TFLs).
With IT, defines our programming environment and its validation.
Responsible for the development of standards, SOPs, and best practices.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company that appears to be mid-sized, offering a collaborative and fast-paced environment.
Author, maintain and implement study-specific Clinical Quality Audit Plan(s) for assigned clinical program(s).
Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As a trailblazer in anti-FcRn technology, they are developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.
Collaborate with Data Management to support data cleaning, external data review, reconciliation, database lock, and data quality activities.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. They have a proven leadership team, a strong financial foundation, and a high-value late-stage asset, making it an outstanding opportunity for mission-driven professionals.
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.
Primary DM contact for assigned clinical project(s) / program(s), ensuring that tasks are performed in a timely manner.
Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing.
Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and advanced data sciences to improve the speed, cost and success rate of bringing therapies to patients. They are expanding in Asia Pacific.
Manage and motivate a team of CRAs to achieve Precision for Medicine’s quality standards.
Support the career development of the organization’s Clinical Research Associate (CRA) workforce.
Strengthen the quality and productivity of operations within the group.
Precision for Medicine is a Clinical Research Organization with a uniquely integrated offering. They combine novel clinical trial designs, industry-leading operational and medical experts, and advanced biomarker and data analytics solutions.
Provide statistical support for Phase I–IV clinical trials.
Participate in protocol development, study design, and sample size calculations.
Prepare and review Statistical Analysis Plans (SAPs), TLF shells, and randomization specifications.
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 4,000 professionals in more than 20 countries with a mission to contribute to a healthier and safer world.
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.
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.