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.
Prepare and maintain Trial Master Files for clinical studies, ensuring completeness and compliance.
Review documentation for accuracy and alignment with protocols and regulations.
Communicate with sponsors, project managers, and sites to resolve documentation issues.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. They foster an inclusive, collaborative, and respectful workplace, utilizing technology to ensure fair recruitment.
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.
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.
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.
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.
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.
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.
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.
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.
Leads the planning, conduct, and oversight of clinical studies per scope of work, ensuring compliance with protocols, SOPs, and regulatory requirements.
Acts as primary clinical point of contact for clients, develops study documents, and drives site feasibility and recruitment strategies.
Manages clinical teams, training, vendor oversight, and ensures data quality and timely deliverables across study phases.
Precision Medicine Group is a clinical research organization that provides outsourced clinical trial management services to pharmaceutical and biotechnology companies. The company fosters a collaborative culture focused on quality and compliance, and employs a team of experienced clinical professionals.
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.
Follow applicable departmental Standard Operating Procedures and Work Instructions to ensure quality and productivity in daily tasks.
Administer controlled documents, maintain inventory, and perform checks to ensure quality and timely escalation of issues.
Ensure regulatory compliance and quality assurance as indicated in controlled documents, while completing required trainings.
Labcorp is a global leader in laboratory services, providing insights and answers to healthcare providers, patients, researchers, pharmaceutical companies and health systems. With nearly 70,000 employees serving clients in more than 100 countries, they foster a culture of innovation and impact.
Drafting, negotiating, and executing clinical site and ancillary agreements in compliance with country regulations and project timelines.
Tracking site contracting progress, providing clear rationales for delays, and escalating issues with contingency plans.
Acting as a country-level subject matter expert on site contracts for internal and sponsor stakeholders.
Ergomed is a specialist clinical research organization focused on rare disease and oncology trials. They have built a collaborative international team across North America, South America, Europe, Asia, and Australia, valuing teamwork, flexibility, and work-life balance.
Create and maintain SOPs and guidance documents in compliance with ICH-GCP and federal and local regulations.
Conduct internal study reviews to ensure compliance and prepare official reports with findings and corrective actions.
Collaborate with operations teams to remediate noncompliance and participate in quality investigations and audits.
Headlands Research is dedicated to enhancing clinical trial delivery within communities. Founded in 2018, the company operates 20+ clinical trial sites across the US and Canada and is rapidly expanding.
Manage execution of study-level activities, including creating trial documents and overseeing vendor delivery and budgets.
Coordinate country and regional trial management, aligning feasibility strategies and mitigating local risks.
Support program-level compound training and mentor new team members in Trial Management.
Johnson & Johnson is a global healthcare innovator focused on preventing, treating, and curing complex diseases through Innovative Medicine and MedTech. With a large workforce, they emphasize an inclusive work environment guided by their Credo, respecting diversity and dignity.
Review, draft, and negotiate a variety of legal agreements including clinical study agreements and confidentiality agreements.
Work closely with Clinical Operations study teams to ensure contract deliverables align with study timelines.
Establish, track, and report site contract metrics and support contract file maintenance.
Precision for Medicine provides clinical research services to the pharmaceutical and biotechnology industries. The company is part of Precision Medicine Group and fosters a collaborative culture focused on precision medicine.
Review, draft, and negotiate legal agreements including CDAs, CTAs, amendments, and site budgets.
Lead interactions with internal study teams and external sites and sponsors to resolve contractual issues.
Coordinate contract execution and maintain accurate contract files and databases.
Precision Medicine Group is a specialized contract research and clinical services organization. It is an equal opportunity employer with a global team, focused on supporting life sciences and biotech clients.