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.
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.
Revise, expand, and optimize onboarding materials and workflows to create a standardized, role-specific, and site-relevant onboarding program.
Deliver hands-on, in-person onboarding and provide ongoing virtual support during the initial integration period and beyond, ensuring continuous guidance and reinforcement of learning.
Contribute to developing, reviewing and maintaining documentation, training templates, study-specific training, and platform-specific user guides tailored to Care Access tools
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, they bring world-class research and health services directly to communities that often face barriers to care.
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 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.
Document and communicate audit findings to management and recommend corrective actions to improve compliance. Provide staff education on privacy standards, compliance policies, and regulatory requirements. Review, investigate, and respond to facility inspections and/or deficiencies issued by regulatory agencies.
SimonMed Imaging is the fastest growing outpatient radiology practice in the Nation and is committed to excellence and improving patient care.
Oversight for traveling clinical staff supporting decentralized operations at events and sites.
Ensure high-quality protocol execution, participant safety, and adherence to GCP and FDA regulations.
Manage, develop, and evaluate all clinical research staff (CRCs, nurses, mobile clinicians, and traveling staff).
Care Access aims to improve the future of health for everyone. With numerous research locations and clinicians globally, they deliver research and health services to communities facing barriers to care.
Oversee the operations of the Imagine Pediatrics Onboarding, Credentialing, Licensing, and Enrollment Department. Develop and train on policies and procedures, workflows, and training documentation for the team. Manage Delegated Credentialing arrangements - implementation and audit – as well as ongoing Delegated partnerships with health plans.
Imagine Pediatrics is a tech enabled, pediatrician led medical group reimagining care for children with special health care needs.
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.
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.
Oversee clinical quality assurance, develop training programs, and ensure regulatory compliance.
Design, implement, and oversee clinical quality assurance programs for in-home care delivery.
Design and implement onboarding and continuing education programs for clinical team members.
Sprinter Health is an innovative healthcare startup dedicated to providing high-quality, in-home and virtual care across the country. They employ a multidisciplinary team of clinicians, technologists and operators backed by investors including a16z, General Catalyst, GV, and Accel.
In this customer-facing role, you’ll enroll users and provide information about training programs. You'll engage with customers to encourage participation and promote courses, driving satisfaction and advocacy. You'll manage invoicing, maintain Excel sheets, and support the management of Approved Trainers and Training Centers.
RWS unlocks global understanding, fundamentally recognizing the value of every language and culture, celebrating difference and believing diversity makes us strong.
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.
Designing, configuring, testing, and supporting eDC systems that meet the data collection needs of study protocols.
Influencing study design, data capture, and compliance with Good Clinical Practice (GCP) standards and FDA/CVM regulations.
Maintaining thorough documentation, validation reports, and data dictionaries.
Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Loyal's team includes scientists, veterinarians, engineers, operators, and creatives, and they are a well-funded startup in growth mode.
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.
Provide operational support for the Field Medical team.
Manage and optimize medical systems—including Veeva, data repositories, and reporting tools.
Develop, implement, and maintain SOPs and operational processes.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company.
Monitor and own the progress of clinical studies at investigative sites.
Coordinate activities to set up and monitor a study.
Train and mentor junior staff members.
Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences to improve the success rate of therapies for patients. They cultivate their culture and have high CRA retention rates compared to industry averages.