Coordinate and assist with trial start-up activities.
Facilitate resolution of laboratory queries.
Track and report on study progress.
Freenome is dedicated to changing the landscape of cancer through early detection. They value diversity and do not discriminate based on various statuses protected by law.
Provide high level logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out for clinical research studies and collaborations
Develop study-related documents with minimal Clinical Trial Manager guidance including: protocol, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required
Manage small to medium size study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites with minimal oversight
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other.
Management and operational delivery of the clinical elements within a trial.
Successful execution of assigned trials and ensuring completion of trial deliverables.
Identify challenges to study timelines/deliverables and offer creative action plans.
Precision for Medicine is a precision medicine CRO with a uniquely integrated offering to enable the science of precision medicine. They achieve this by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions. They are dedicated to positively impacting the health and lives of patients around the world, particularly in rare diseases and oncology.
Performs on-site or remote monitoring visit activities.
Identifies investigators and verifies qualifications and resources.
Trains investigational site staff and supports regulatory submissions.
Ergomed is a rapidly expanding full-service mid-sized CRO specializing in Oncology and Rare Disease. The company has operations in Europe, North America, and Asia, fostering an international culture with employee well-being and career development opportunities.
Oversees all aspects of study site management to ensure patient safety is protected and quality of data is generated.
Independently conducts all forms of site visits in accordance with the protocol, local laws, ICH-GCP and Precision SOPs.
Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management.
Precision for Medicine is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, advanced biomarker and data analytics solutions, and a real passion for complex disease states. They strive to ensure employees feel appreciated through a multitude of benefits and value their ideas and contributions.
Support the design, specifications, and development of eCRFs
Develop Data Management Plan documents
Manage effective communication of data issues and discrepancies to study sites via the query management process
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 and redefining what’s possible.
Track and monitor clinical staff training completion, including study-specific and mandatory compliance training.
Support DOA matrix setup and maintenance by confirming training completion and role assignments.
Upload and maintain essential staff training records, certifications, and staff documents in the eISF and associated systems.
Care Access aims to improve the future of health for everyone by bringing research and health services to communities. They operate with hundreds of research locations and mobile clinics across the globe and are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to medical breakthroughs.
Develop, review, and update study-related training materials and documents.
Serve as Subject Matter Expert for clinical sites and provide guidance on protocol interpretation and eligibility requirements.
Partner with field Clinical Research Associates (CRAs) and CTAs to resolve issues identified during site visits.
ImmunityBio is a commercial-stage biotechnology company focused on developing cell and immunotherapy products designed to strengthen the immune system to eliminate cancerous or infected cells. They are publicly traded with headquarters in Southern California, working collaboratively to transform the lives of patients.
Oversee clinical budgets and develop monitoring plans for effective study oversight.
Train and mentor Clinical Research Associates (CRAs) to optimize their performance.
Drive enrollment and lead study start-up activities, adhering to timelines.
Jobgether employs AI to match candidates to job openings, ensuring fair and objective reviews. They connect top candidates with hiring companies, who then manage the final decisions and interview process.
Assess eligibility, interest, and availability of trial candidates via phone, email, and text.
Communicate with site personnel to schedule visits and discuss program and participant statuses.
Provide recruitment-related support and address questions or concerns from site personnel.
CrowdPharm, a Spectrum Science Company, focuses on delivering qualified trial candidates to clinical trial sites. While specific employee numbers aren't provided, Spectrum Science is a prominent player known for its collaborative and innovative culture.
Provides regulatory guidance throughout the clinical development life cycle.
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
Keeps abreast and continually expands knowledge of laws, regulations and guidelines governing drug development and approval.
Precision Medicine Group is a company that works in the clinical trial space. They are an equal opportunity employer that values diversity and does not discriminate based on race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Clinical quality compliance oversight for our clinical development programs both in the US and internationally.
Independently manage domestic and international risk-based audits of investigator sites, study documents, databases, vendors, partners, and internal systems.
Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, we are committed to transforming the future of treatment for autoimmune disease.
Prepare and follow through on bids for new business.
Oversee financial and contractual performance of Sponsor projects.
Maintain a strong relationship with the customer during an ongoing clinical trial.
Jobgether is a platform that connects job seekers with potential employers. The company uses AI-powered matching to ensure applications are reviewed quickly and objectively.
Support the development and refinement of study documents under the guidance of senior clinical scientists.
Conduct routine clinical data reviews to ensure data quality, completeness, and medical plausibility.
Partner with clinical scientists, statisticians, and medical directors to extract and interpret scientific data for abstracts, posters, presentations, and manuscripts.
Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other.