Provide administrative and regulatory support for the activation, maintenance, monitoring, and closeout of clinical research studies.
Assist Regulatory Coordinators with regulatory startup, continuing review, amendments, and study closeout activities.
Maintain study regulatory files and binders, ensuring documentation is complete, current, and audit-ready.
Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington and operates eight clinical care sites with network affiliations in five states.
Develop global clinical trial budget templates by translating complex protocols into site-level costs.
Review, draft, and negotiate legal agreements including confidentiality agreements and clinical study agreements.
Collaborate with Clinical Operations study teams to ensure budget deliverables meet study timelines.
Precision for Medicine is a clinical research organization that specializes in global clinical trial budget development and contract management. The company's size and culture are not specified in the posting, but the role offers remote work across several European countries.
Serve as primary medical and scientific expert for clinical trial protocols and Expanded Access Programs.
Monitor trials to ensure participant safety, data accuracy, and protocol compliance.
Lead protocol development, investigator training, and cross-functional collaboration.
WEP Clinical partners with biopharmaceutical sponsors to deliver clinical trials, expanded access programs, and market access solutions. With 15+ years of experience across 150+ countries, they offer operational scale and a personalised culture.
Lead clinical research project planning, execution, and delivery, ensuring regulatory compliance and quality.
Coordinate cross-functional teams and manage timelines, budgets, and study documentation.
Serve as the primary sponsor and client contact, providing regular project updates and resolving issues.
Alimentiv is a global CRO advancing therapies for gastrointestinal diseases, with deep expertise in IBD drug development. With about 700 employees across multiple countries, it is a private, profit-with-purpose company focused on scientific research and its people.
Track and monitor clinical staff training completion and compliance documentation across studies.
Support DOA matrix setup and maintenance, verifying training aligns with assigned roles.
Maintain audit-ready staff training records in eISF and collaborate cross-functionally for study compliance.
Care Access brings clinical research and health services directly to communities worldwide, operating hundreds of research locations and mobile clinics. The company is dedicated to making health more accessible, with an inclusive culture focused on people and medical progress.
Act as a resource for protocol and compliance questions, serving as an expert on the Client Portal for document management.
Review contracts to extract protocol, build it into tracking systems, and ensure all updates are communicated to appropriate team members.
Collaborate with sales, onboarding, MSP, and IT teams to support project implementation and integration.
Medical Solutions is a leader in the medical staffing industry, connecting healthcare professionals with facilities across the country. The company emphasizes quality, compliance, and a collaborative team environment.
Provide medical oversight for clinical trials, safeguarding participant safety and ensuring protocol compliance.
Review adverse events and safety data, contributing to regulatory reporting and clinical documentation.
Collaborate with investigators and clinical teams to support study design, execution, and risk management.
This position is listed on behalf of a partner company that manages all applications and next steps. The role supports global clinical research in a remote working environment with cross-functional collaboration.
Lead the planning, authoring, and delivery of regulatory documents for global development programs, health authority interactions, and marketing applications.
Develop strategic document plans and author complex submissions such as INDs, CTAs, IBs, CSRs, and briefing packages while ensuring ICH/GCP compliance.
Coordinate cross-functional teams, manage external vendors, mentor junior writers, and drive process improvements to maintain submission readiness.
The company is a biopharmaceutical organization focused on developing innovative therapies for patients with significant unmet medical needs. It operates as a remote, cross-functional team with a culture emphasizing regulatory excellence, collaboration, and career development.
Manage regulatory submissions and site activation readiness across the UK.
Negotiate budgets and contracts with sites and vendors.
Coordinate with ethics committees and competent authorities for approvals.
Precision for Medicine is a global Clinical Research Organization that combines novel clinical trial designs, operational and medical experts, advanced biomarker and data analytics, and a passion for rare diseases and oncology. The company values growth and innovation, fostering a collaborative and inclusive environment.
Monitor and own study progress at sites, ensuring compliance with protocol, SOPs, ICH-GCP, and regulations.
Coordinate setup: investigators, regulatory submissions, pre-study and initiation visits.
Identify risks, propose mitigations, and become a protocol expert with a lower protocol load.
Precision for Medicine is a clinical research organization that combines novel clinical trial designs, advanced biomarker and data analytics, and specialized expertise in rare diseases and oncology. It is a smaller CRO with high CRA retention, a supportive culture, and a focus on giving employees influence and impact.
Lead medical writing for one or more clinical programs and drive content strategy for clinical and regulatory documents.
Author and manage high-quality clinical study protocols, investigator's brochures, clinical study reports, and global regulatory submissions.
Collaborate cross-functionally, mentor direct reports, and incorporate process improvements to support R&D needs.
Deciphera is a biopharmaceutical company dedicated to developing innovative medicines for people living with cancer. They value diversity and offer a competitive compensation and benefits package, fostering a culture of collaboration and professional growth.
Coordinate clinical trial site activities and support successful site start-up and activation.
Serve as a primary point of contact for investigative sites, facilitating communication among clinical teams, sponsors, CROs, and regulatory stakeholders.
Ensure compliance with ICH/GCP guidelines, manage essential documentation, regulatory submissions, and site activation milestones.
This role is listed on behalf of a partner company in the clinical research sector, focused on coordinating site start-up and activation for clinical trials. The culture emphasizes operational excellence, collaboration, and patient safety, with a remote working environment.
Lead ongoing clinical data review to ensure quality, interpretation, and patient safety across development programs.
Develop and review study protocols, investigator brochures, and regulatory documents in partnership with cross-functional teams.
Represent Clinical Development on study teams and present clinical data and scientific information to internal and external audiences.
Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company discovering, developing, and commercializing new medicines for cancer, neurologic, and autoimmune disease. They cultivate an inclusive culture valuing curiosity, creativity, and shared accountability, empowering individuals to challenge the unknown together.
Collaborate with project teams to support study startup and serve as primary point of contact for clinical sites.
Provide training on Beacon's devices and protocols, monitor progress, and maintain GCP/ICH compliance.
Address operational issues via Zendesk and Asana and deliver actionable site feedback for workflow improvements.
Beacon Biosignals is transforming precision medicine for the brain with at-home EEG and cardiopulmonary monitoring platforms for clinical development and diagnostics. They foster a remote-first culture with hubs in Boston, New York, and Paris, emphasizing curiosity, simplicity, and empathy.
Monitor clinical studies at investigative sites to ensure compliance with protocols, SOPs, and ICH-GCP.
Coordinate study setup and initiation activities, including investigator identification and regulatory submissions.
Identify study risks and propose mitigation strategies while maintaining high quality and detail.
Precision for Medicine is a CRO integrating clinical trial execution with scientific expertise and data sciences, focusing on Oncology and Rare Disease. It offers a supportive, small-CRO culture with high CRA retention and emphasis on work-life balance.