Engage with patients to recruit, educate, and pre-screen them for clinical studies.
Maintain data accuracy across multiple study portals and manage data entry and queries.
Collaborate with site teams and PIs to ensure protocol compliance and resolve issues.
Care Access brings world-class research and health services directly to communities, working to make the future of health better for all. With hundreds of research locations and a global team, we are dedicated to ensuring every person can contribute to medical breakthroughs.
Provide study oversight as the primary liaison between CRAs, site staff, clients, and vendors across all study stages.
Ensure clinical monitoring activities comply with SOPs, regulations, GCPs, and study-specific requirements.
Support team training, review site visit reports, and manage oversight of the Trial Master File and eTMF.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) trusted since 1996, delivering ethical services to pharmaceutical, biotech, and medical device companies. They foster a collaborative community where team members feel valued and empowered to make a meaningful impact on global health.
Collaborate with project teams and clinical sites to support study startup, training, and device deployment.
Ensure compliance with GCP, ICH guidelines, and regulatory standards while monitoring project progress.
Address operational issues and provide feedback to improve devices and workflows.
Beacon Biosignals is transforming precision medicine for the brain by offering at-home EEG platforms for clinical development and diagnostics. The company fosters a remote-first culture with office hubs in Boston, New York, and Paris, emphasizing asynchronous work and collaboration.
Provide regulatory guidance throughout the clinical development lifecycle and prepare quality regulatory submissions.
Compile, coordinate, and review applications to regulatory authorities, including CTA/IND and amendments.
Represent Global Regulatory Affairs at project team and business development meetings, overseeing Regulatory Affairs Specialists.
Precision Medicine Group is a life sciences company providing clinical research, regulatory, and commercial services to biopharmaceutical clients. It fosters a collaborative, quality-focused culture and is an Equal Opportunity Employer.
Establish and maintain relationships with investigators, sites, and key opinion leaders to support trial execution.
Gather site feedback and translate it into actionable improvements for study teams.
Contribute to protocol development, site selection, and business development activities.
This role is with a partner company that focuses on clinical research and trial execution. The company operates remotely and values collaboration, inclusion, and professional autonomy.
Identify, source, and manage clinical vendor relationships to support study objectives and cost-effective procurement.
Review clinical protocols to determine vendor scope, lead RFPs, and negotiate contracts with legal and finance teams.
Monitor vendor performance, resolve issues, and drive continuous improvement across clinical operations.
Care Access brings world-class clinical research and health services directly to communities, with hundreds of locations and clinicians globally. They are dedicated to building a more accessible future of health, emphasizing people at the heart of medical progress.
Serve as a senior clinical resource guiding complex clinical trials, research, and data-collection activities.
Recruit and collaborate with clinical investigators on study design, costs, timelines, and execution.
Oversee Phase III and Phase IV human clinical trials and ensure adherence to protocols and regulatory requirements.
This role is listed on behalf of a partner company that supports innovative, minimally invasive solutions in the vascular care space. They offer opportunities for professional growth within a global healthcare environment.
Support study execution by managing meeting logistics, documenting decisions, and tracking action items.
Partner with Clinical Operations and site monitors to ensure protocol compliance and quality standards.
Responsible for filing site-level documents into Trial Master Files and assisting with regulatory submissions.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. As a small, mission-driven team, we foster a collaborative culture built on trust, ownership, curiosity, and results.
Conduct risk-based quality control assessments and on-site visits to ensure investigational sites adhere to study protocols, GCP, and company procedures.
Develop and maintain study-specific QC plans, tools, and reports, and drive trend analysis and issue resolution with clinical operations teams.
Support inspection readiness and contribute to training and process improvements based on QC findings and regulatory insights.
Zai Lab is a commercial-stage biopharmaceutical company focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and worldwide. Founded in 2014, the company has a global team of about 2,000 employees, with a strong commitment to gender diversity and a culture that promotes women in biotech.
Serve as the primary point of contact for assigned protocols, linking Country Operations with the clinical trial team.
Manage project timelines, deliverables, and performance for clinical studies from feasibility to close out.
Ensure compliance with ICH/GCP, country regulations, and company policies while leading local study teams.
Merck is a global healthcare leader with a diverse range of prescription medicines, vaccines, and animal health products. With over 100 years of history, the company employs tens of thousands worldwide and fosters a culture of innovation and inclusivity.
Serve as primary contact for data management timelines, deliverables, and technical issues across clinical projects.
Oversee database design, UAT testing, data validation, and quality reviews to ensure compliance.
Train study teams, manage project resources, and support audits and bid defense meetings.
The company is a partner firm managing clinical data for life sciences research. They foster a collaborative, quality-focused culture and support professional development.
Support identification and tracking of pipeline opportunities in clinical imaging.
Coordinate proposals, client requests, and commercial documentation.
Maintain CRM records and assist with pricing and sales operations.
The company operates in the clinical imaging and clinical trials space, supporting the generation of high-quality clinical evidence. It offers an inclusive and collaborative global work environment with a focus on professional growth.
Develop and maintain successful working relationships with study sites, serving as the primary point of contact for clinical trial operations.
Conduct monitoring visits to ensure compliance with protocols, GCP, and regulatory requirements, preparing high-quality reports.
Collaborate with cross-functional teams including Clinical Project Managers, Data Management, and Regulatory Affairs to ensure end-to-end study execution.
CVRx pioneers unique therapies that harness and harmonize the body's natural systems, benefiting society and making CVRx a universal role model in healthcare. The company values commitments to others and fosters a culture of teamwork, collaboration, and positivity in a purpose-driven startup environment.
Coordinate day-to-day execution of clinical studies including site onboarding, documentation, and timeline tracking.
Support regulatory compliance through IRB submissions, amendments, and maintaining study documentation.
Collaborate cross-functionally with science, bioinformatics, and product teams to ensure study operations.
Tiny Health advances lifelong health through precision microbiome science using shotgun metagenomics and AI. Founded in 2020, it is a remote-first startup with a diverse international team focused on making the microbiome measurable and actionable.
Conduct validation studies on Chemistry and Immunoassay diagnostic instruments for customer laboratories.
Provide onsite and remote technical support, training, and troubleshooting for assay and quality-control issues.
Collaborate with internal teams and travel extensively to support customers across the Northeastern US.
They provide Chemistry and Immunoassay diagnostic instrumentation and support services to healthcare laboratories. Their culture emphasizes customer education, technical validation, and collaborative teamwork across field service, sales, and training teams.
Oversee clinical study operations from startup through close-out, ensuring quality and compliance.
Act as primary operational partner to sponsors, project teams, and clinical sites.
Foster a culture of quality by coaching peers on GCP compliance and documentation discipline.
Beacon Biosignals is transforming precision medicine for the brain, offering EEG and cardiopulmonary platforms for clinical development and diagnostics. The company has office hubs in Boston, New York, and Paris, and fosters a first-class remote work culture with a focus on diversity and impact.
Independently manages significant aspects of clinical trials and research projects.
Trains and provides guidance to less experienced staff, and oversees data management.
Ensures compliance with regulations, monitors IRB submissions, and interfaces with study sponsors.
Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate and prepare leaders for the future. The university is committed to diversity and inclusion, providing a supportive environment for staff and faculty.
Coordinate participant recruitment start-up activities for assigned clinical trials, managing timelines and cross-functional communication.
Manage sponsor-funded recruitment budgets, including tracking, forecasting, and reporting to leadership.
Oversee external vendors and ensure participant-facing materials meet regulatory and sponsor requirements.
Our partner is a clinical research organization managing participant recruitment for clinical trials. This is a remote opportunity within a growing multi-site network that values cross-functional collaboration.
Review CMC sections of regulatory submissions for drug-device combination products, ensuring accuracy and alignment with global requirements.
Contribute to global regulatory CMC strategies and provide guidance to cross-functional stakeholders.
Collaborate with device development, quality, clinical, human factors, and other teams to support product compliance and change controls.
The company specializes in drug-device combination products and operates in a cross-functional, science-driven environment. The culture emphasizes collaboration across regulatory, device development, quality, clinical, and human factors teams.
Provide regulatory affairs support for FDA medical device compliance, including pre-market submissions (510(k), PMA), post-market surveillance, and quality system audits.
Collaborate cross-functionally with R&D, Quality Assurance, and Sales to ensure compliance with U.S. FDA and international regulations (ISO 13485, MDSAP, EU MDR).
Perform regulatory documentation and submissions for new products and changes, and handle customer complaints, field actions, and risk assessments.
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions spanning diagnostic imaging, enterprise imaging, endoscopic and surgical imaging, and in-vitro diagnostics. The company is part of Fujifilm, which has over 70,000 employees globally and fosters a dynamic, flexible environment focused on innovation and collaboration.