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.
Monitor clinical trial sites to ensure ethical, safe, and compliant conduct per protocol, GCP, and regulations.
Serve as primary liaison between Lycia and investigative sites for startup, maintenance, and close-out activities.
Manage regulatory documents, EDC data queries, and remote monitoring to maintain audit-ready TMF and CTMS records.
Lycia Therapeutics is a clinical-stage biotechnology company developing LYTAC-based therapeutics to degrade disease-driving proteins. It went public in 2026 and is headquartered in South San Francisco, California.
Partner with cross-functional teams and study sites to support clinical operations across all trial phases.
Perform remote monitoring of clinical trials and serve as secondary contact for sites supporting CRAs.
Ensure proper reporting and follow-up of SAEs, address non-compliance issues, and assist with audit/inspection readiness.
Premier Research is a global clinical research, product development, and consulting company helping biotech, specialty pharma, and MedTech innovators turn breakthroughs into new treatments. The company fosters a collaborative culture focused on agility, continuous learning, and making an impact.
Support Rater Training Program and serve as liaison across teams
Manage study reporting and ensure timely deliverable completion
Mentor junior team members and lead small studies
Cogstate advances brain health by providing digital cognitive assessments used in clinical trials and healthcare settings. With a global team of experts, the company supports over 2,000 clinical trials across 150+ countries in a collaborative, patient-first culture.
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.
Lead preparation of state authorization applications, renewals, annual reports, and related filings.
Research and monitor state regulatory requirements affecting academic programs and distance education.
Develop and maintain compliance calendars, tracking systems, and documentation repositories.
Saybrook University is a non-profit, regionally accredited university known for humanistic studies and rigorous research. It offers advanced degrees in psychology, counseling, and organizational systems, and fosters a diverse and inclusive community.
Prepare and submit clinical trial applications to Competent Authorities and Ethics Committees, ensuring compliance with local and international regulations.
Manage essential documents, informed consent forms, and site activation readiness, mitigating risks to timelines.
Act as subject matter expert and mentor for site start-up activities, maintaining regulatory intelligence and audit readiness.
Precision Medicine Group provides clinical trial services, including regulatory and site start-up support. The company is expanding across Latin America and values expertise, collaboration, and compliance.
Independently manage site monitoring activities for wound care clinical trials, ensuring data integrity and GCP compliance.
Collaborate with sponsors, investigators, and cross-functional teams to resolve issues and support effective trial delivery.
Contribute to study planning, regulatory documentation, audit readiness, and patient recruitment oversight.
The company is a clinical research organization focused on wound care trials. It offers a collaborative, international, and innovation-driven culture with opportunities for professional development and flexible remote work.
Maintain compliance policies, annual reviews, and state-specific scope-of-practice requirements.
Deliver compliance training, administer the hotline, and conduct investigations.
Execute audit and monitoring plans, support payer audits, and coordinate corrective actions.
Herself Health provides primary care designed for women 65 and older, focusing on post-menopausal care, bone health, and mental well-being. It is a growing organization with a collaborative, patient-first culture that values curiosity, ownership, and teamwork.
Provide compliance documentation and knowledge management support to the Contracts Management and Compliance Division.
Maintain the organization-wide risk register, track mitigation actions, and support sub-recipient due diligence workflows.
Coordinate compliance training, monitor U.S. government regulatory updates, and prepare compliance reports for leadership.
Jhpiego is a global health nonprofit affiliated with Johns Hopkins University, dedicated to improving the health of women and families in developing countries. The organization values diversity, equity, and inclusion, and offers a supportive, mission-driven work culture.
Oversee GCP compliance, manage deviations and CAPAs, and conduct quality and TMF reviews.
Maintain inspection readiness and support CRO oversight per ICH E6(R3).
Collaborate with Data and Clinical teams to embed compliance into workflows and train teams.
Resilience Care is a French medtech founded in 2021, offering AI remote monitoring for oncology, gastroenterology, and psychiatry. It serves 35,000 patients across 200+ facilities with an agile, collaborative culture.
Independently manage assigned clinical trial activities in compliance with GCP and regulations.
Oversee essential study documentation, TMF completeness, and study trackers.
Manage vendors, CTMS activities, and cross-functional coordination to ensure compliant study execution.
Cognito Therapeutics is a neurotechnology company developing a new therapeutic approach to cognitive and neurological health, including an investigational therapy for Alzheimer's disease. The company is an interdisciplinary team united by a shared purpose of protecting and progressing the human ability to think, learn and remember.
Serve as the primary clinical point of contact with clients, overseeing the operational portion of clinical studies per scope of work.
Develop study-related clinical documents, train CRAs and vendors, and lead internal clinical team meetings to ensure trial compliance.
Drive site feasibility, recruitment and retention strategies, and manage eTMF, budgets, and vendor oversight to ensure quality and timelines.
Precision for Medicine is a CRO that 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, with a strong focus on Oncology and Rare Disease. The company combines new technologies, operational scale, and a collaborative environment to support the life sciences industry.
Perform on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visits to ensure sites are adequate for study conduct.
Verify investigator qualifications, resources, facilities, equipment, and staff for clinical study conduct.
Train site staff, support regulatory/EC submissions, and mentor junior staff during co-monitoring visits.
Ergomed Group is a global clinical research organization helping biopharmaceutical companies develop and deliver therapies in oncology, rare disease and other complex areas. Its diverse teams across countries and time zones collaborate with kindness, curiosity and a shared sense of purpose.
Conduct and report all types of onsite monitoring visits, including CRF review and source document verification.
Manage site communication and serve as the point of contact for in-house support services and vendors.
Support regulatory document preparation and participate in feasibility research for clinical studies.
We are a global CRO founded in 1995, working on the frontline of medical science to bring new medicines to patients. We bring together over 3000 dedicated professionals in a culture that cares for staff, clients, partners, and quality.
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.
Lead GCP quality for clinical studies as the primary Quality point of contact from start-up through close-out.
Build the GCP quality framework, authoring SOPs, quality plans, and risk management aligned with ICH E6(R3).
Qualify and audit CROs, clinical sites, and vendors, and partner on inspection readiness.
Osanni Bio is a development-stage therapeutics platform headquartered in San Francisco, California, advancing programs in ophthalmology, cardiology, and beyond. They are a creative, agile team of innovators guided by core values of integrity, impact, agility, and collaboration.
Supervise and train the credentialing associate team to ensure high performance.
Document and refine insurance credentialing workflows and processes.
Collaborate with the Credentialing Team Lead and partners to monitor metrics and resolve issues.
BetterHelp is the world's largest online therapy service, connecting millions of people with licensed therapists to make mental healthcare more accessible. As part of Teladoc Health, it offers startup energy with the support of a large company and a diverse, collaborative culture.
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.
Conduct and report all types of onsite monitoring visits and be involved in study startup.
Perform CRF review, source document verification, and query resolution while managing site communication.
Support regulatory team in preparing documents and participate in feasibility research.
PSI is a leading Contract Research Organization with 30 years in the industry, offering a balance between stability and innovation to clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.