Prepare and maintain Trial Master Files for internal and external studies to meet sponsor specifications.
Communicate with sponsors, project managers, and study contacts to ensure compliance with protocols and regulatory requirements.
Manage multiple priorities and ensure file structure and indexing are accurate.
Celerion is a clinical research organization that uses translational medicine to accelerate drug development. The company values integrity, trust, teamwork, and respect, and is an equal opportunity employer.
Serves as regulatory document specialist for clinical trial start-up, maintenance, and close-out.
Collects, reviews, and maintains essential documents in the electronic Trial Master File (eTMF).
Communicates with study teams and sites to ensure regulatory files remain complete and inspection-ready.
St. Jude Children’s Research Hospital is a leading research and treatment center focused on pediatric catastrophic diseases. It is a large institution with a collaborative culture and a strong emphasis on finding cures and saving children.
Prepare and ensure completeness of Trial Master Files for internal and external studies.
Maintain the Trial Master File, creating file structure and indexing contents.
Communicate with client sponsors, project managers, monitors, and sites to ensure compliance.
Celerion is a performance-driven drug research company operating in the clinical research industry. They focus on integrity, trust, teamwork, and respect, offering a strong developmental environment.
Support clinical trial activities across patient engagement, study coordination, recruitment, regulatory support, data management, and operations.
Coordinate participant visits, recruitment, and regulatory documentation while maintaining accurate information in clinical research systems.
Foster communication between sponsors, CROs, investigators, and sites to ensure study compliance and milestone achievement.
This partner company supports fast-growing remote clinical research environments, helping keep clinical trials organized, compliant, and moving forward. They collaborate with research sites, sponsors, CROs, and healthcare organizations globally, offering multidisciplinary roles in a remote setting.
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.
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.
Serve as TMF subject matter expert, partnering with study teams to ensure documentation is complete and inspection ready.
Lead the setup, maintenance, and quality review of electronic Trial Master Files, monitoring health and driving issue resolution.
Collaborate with clinical operations and vendors to improve TMF processes and support regulatory inspections.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company developing therapies for central nervous system disorders. With a focus on trust, ownership, curiosity, and results, they foster a collaborative, inclusive culture.
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.
Creates and executes the study TMF Plan and ensures team understanding of expectations.
Monitors and reports on TMF Health to internal team and sponsor, identifying trends and risks.
Serves as point of contact for audits and inspections, and supports process improvement initiatives.
Precision for Medicine is a clinical research organization that provides services for drug development, including trial management and regulatory compliance. The company fosters a collaborative environment with a focus on quality and innovation.
Oversee study start-up, site activation, and close-out activities while managing study plans and essential documents.
Collaborate with cross-functional teams, sponsors, and vendors to ensure timely and compliant project execution.
Mentor CTA team members and contribute to TMF quality, inspection readiness, and regulatory compliance.
ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. They are a collaborative community committed to making a meaningful impact on global health, valuing team members and empowering them.
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.
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.
Organize and maintain electronic records and files with accuracy.
Update, verify, and retrieve digital records as needed.
Ensure confidentiality and complete tasks within deadlines.
Medi Transcare Pvt. Ltd provides services in the healthcare transportation industry. The company fosters a remote work culture with a focus on independent and detail-oriented administrative support.
Complete pre-charting and post-charting of comprehensive home health assessments in MatrixCare EMR.
Ensure documentation accuracy, compliance with regulatory standards, and strict confidentiality per HIPAA.
Collaborate with nurses to review and finalize patient records while maintaining strong attention to detail.
Limitlessli specializes in recruiting, hiring, and managing high-caliber remote staff through a global network. They connect clients with qualified professionals and offer tailored services to meet unique business needs.
Critically evaluate scientific literature and produce accurate regulatory documents.
Manage writing assignments across multiple projects and ensure timely delivery.
Work directly with clients and multidisciplinary teams on regulatory submissions.
A partner company in the pharmaceutical, biotechnology, and medical device sectors is hiring a Senior Medical Writer. The company offers a fully remote environment and opportunities to work on a broad portfolio of clinical and regulatory documents.
Bilgewater Group is a company that specializes in document processing and administrative services. They are an equal opportunity employer committed to providing a remote work environment.
Coordinate and manage client service projects, including scheduling meetings, preparing materials, and tracking timelines.
Communicate with clients to provide updates, gather information, and respond to inquiries professionally.
Support development and distribution of project reports, presentations, and deliverables; maintain project documentation and databases.
The American Institutes for Research (AIR) is a nonpartisan, not-for-profit organization conducting behavioral and social science research and delivering technical assistance to address pressing challenges in the U.S. and globally. It has been operating since 1946 and employs a diverse team of professionals dedicated to evidence-based solutions.
Support accurate setup and management of clinical trial payment processes, ensuring timely and compliant financial support.
Collaborate with internal teams, clients, and sites to configure payment systems and resolve operational challenges.
Maintain data accuracy, improve workflows, and contribute to clinical research delivery.
Jobgether uses AI to match candidates with jobs, focusing on objective review and fair hiring. They operate globally with a collaborative culture and process personal data under GDPR.