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.
Support operational planning, start-up, execution, and close-out activities for Phase 3 clinical studies in HCM.
Oversee CROs, vendors, clinical sites, and external partners to ensure delivery of high-quality data, adherence to timelines, and compliance with GCP and regulatory requirements.
Lead selection, onboarding, and oversight of CROs, central labs, imaging vendors, and specialty service providers.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease.
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.
Directly manage a remote team of Care Partners, providing guidance and support.
Design and improve operational processes to ensure high clinical quality.
Monitor key performance indicators to measure success across different teams.
Medsien provides scalable remote care management for a quality patient experience. Hundreds of organizations trust Medsien's technology solutions to implement remote care management programs, personalize every interaction, and improve the lives of the people who need it most.
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.
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.
Lead and optimize the organization’s operational processes, focusing on efficiency, quality, and compliance.
Oversee clinical forms processing, implement workflow improvements, and ensure timely and accurate delivery of services.
Mentor and develop your team, establish performance standards, and collaborate with senior leadership to execute operational strategies.
This position is posted by Jobgether on behalf of a partner company; they use an AI-powered matching process to ensure your application is reviewed quickly and fairly.
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.
Manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities.
Serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs.
Contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies.
Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease.
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.
Manage clinical trials from inception to Clinical Study Report completion to drive meaningful change for patients and healthcare providers. Author and implement operational plans for efficient study enrollment and monitoring activities. Participate in audits and regulatory inspections as needed.
This position is posted by Jobgether on behalf of a partner company.
As Clinical Trial Manager, you will lead CRAs and oversee clinical aspects of studies across multiple countries. You will ensure timeline adherence and scope, whilst ensuring quality delivery. Management and operational delivery of the clinical elements within a trial including site selection, start-up, and data cleaning activities. Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor.
Precision for Medicine is a precision medicine CRO which combines novel clinical trial designs, experts and biomarker solutions.
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.
Accountable for the operational management and execution of global clinical trial programs (Phases I-III). Ensure adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. Partner with CROs and other 3rd party vendors to oversee and ensure study milestones and deliverables are achieved according to agreed quality standards and timelines.
Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of inflammatory and immunology indications.
Provides regulatory guidance throughout the clinical development life cycle
Compile, coordinate and review applications to Regulatory Authorities
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees
Precision for Medicine integrates clinical trial execution with scientific knowledge, lab expertise, and data science to improve the speed, cost, and success rate of life-changing therapies. They focus on Oncology and Rare Disease and value employee contributions.
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.
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.