Monitor clinical studies of investigational and approved products.
Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion.
Review data queries and listings, and work with the study centers to resolve data discrepancies.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. They believe great work happens when team members feel valued, supported, and empowered, and they are committed to making a meaningful impact on global health.
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.
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.
Monitor and own the progress of clinical studies at investigative sites.
Coordinate all necessary activities required to set up and monitor a study.
Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.
Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve the speed, cost and success rate of bringing life-changing therapies to patients. They have a strong focus on Oncology and Rare Disease and boast extremely high CRA retention rates compared to industry averages.
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.
Prepare, track, and maintain all correspondence and regulatory documentation required by the IRB, FDA and other institutional and federal oversight committees.
Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations.
Maintain study regulatory binders and files and perform internal audit and quality assurance checks on regulatory documents.
Fred Hutchinson Cancer Center is a non-profit organization focused on adult cancer treatment and research. They are based in Seattle and have a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines.
Support senior leaders and team and serve as a flexible resource across Medical Affairs projects.
Manage schedules, including calendar management, meeting scheduling, travel arrangements and expenses.
Assist with the preparation of presentations, and other materials as needed.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company with employees working collaboratively.
Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
Collaborating with investigators and site staff to facilitate smooth study conduct.
ICON plc is a world-leading healthcare intelligence and clinical research organization. ICON fosters an inclusive environment driving innovation and excellence.
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.
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.
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.
Support daily operations of study coordinators and clinical staff, escalating challenges and suggesting solutions.
Assist in documenting processes and workflows to simplify daily work and focus on patients.
Provide system and process support to team members, answering questions and assisting with training.
Care Access aims to improve the future of health for everyone. They bring research and health services to communities through research locations, mobile clinics, and clinicians across the globe.
Assist with daily site activities, acting as the primary point of contact for the site.
Assist with training and mentoring research staff, upholding professional development goals.
Promote strict adherence to ICH-GCP, FDA, and local regulations, maintaining audit readiness across all studies.
Care Access aims to improve the future of health for everyone. They operate globally with research locations, mobile clinics, and clinicians, bringing health services to communities, and are dedicated to ensuring every person can understand their health, access care, and contribute to medical progress.