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.
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.
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.
Create eSource for new studies according to protocol specifications.
Distribute eSource to applicable sites and collaborate with local staff to ensure site-specific eSource requirements are implemented.
Serve as a subject matter expert for eSource creation and mentor clinical sites.
Headlands Research is a leading network of advanced clinical trial sites dedicated to enhancing clinical trial delivery within communities using cutting-edge technology and exceptional support services. Founded in 2018, the rapidly growing company currently operates 20+ sites across the US and Canada with a mission-driven culture focused on advancing medicine.
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.
Coordinates complex clinical research studies, including protocol development, participant recruitment, and data management.
Acts as a liaison between investigators, sponsoring agencies, and study participants to ensure compliance with regulatory requirements.
Analyzes qualitative and quantitative data, prepares reports, and assists in manuscript and grant proposal preparation.
Washington University in St. Louis is a private research university dedicated to advancing knowledge and improving lives through education, research, and patient care. It employs over 15,000 faculty and staff and fosters a culture of collaboration, innovation, and inclusivity.
Monitor clinical trial sites to ensure compliance with protocols, SOPs, and regulatory requirements.
Review electronic medical records and source documentation for accuracy and data integrity.
Support site staff and contribute to development of trial materials, SOPs, and training guides.
Orca Bio is a commercial-stage biotechnology company developing next-generation cell therapies to improve transplant outcomes for blood cancer patients. The company maintains a start-up culture with an entrepreneurial spirit and emphasis on camaraderie.
Develop Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) per EU MDR to support CE Mark submissions.
Interact with cross-functional teams to define strategies for clinical documentation and regulatory submissions.
Conduct literature searches, critically appraise scientific data, and write clinical summaries for products and surgical procedures.
Intuitive is a global leader in robotic-assisted surgery and minimally invasive care, developing technologies like the da Vinci surgical system and Ion to transform surgery. The company is a team of engineers, clinicians, and innovators united by a purpose to make surgery smarter, safer, and more human, with challenging but deeply meaningful work.
Manage end-to-end clinical studies ensuring on-time and on-budget delivery with high quality standards.
Lead multifunctional study management teams and serve as primary point of contact for client study teams.
Oversee project planning, resource allocation, and financial management while ensuring regulatory compliance.
Science 37 is a clinical research organization focused on decentralized clinical trials. They value employee well-being and provide an equal opportunity workplace.
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.
Conduct comprehensive program evaluation for tools and trainings.
Support development and maintenance of detailed project plans, timelines, and budgets.
Spring Health is a global mental health company eliminating every barrier to mental health. They reach over 170 million people worldwide through leading employers, health plans, and partners, and are an AI-native company focused on personalized care.
Conduct and report all types of onsite monitoring visits, perform CRF review, source document verification, and query resolution.
Be responsible for site communication and management, supervise study activities, timelines, and schedules on the country level.
Support regulatory team in preparing documents for study submissions and participate in feasibility research.
PSI is a leading Contract Research Organization with over 30 years of experience, offering a balance of stability and innovation. The company focuses on delivering quality and on-time services across a variety of therapeutic indications.
Assist in preparing clean databases by reviewing clinical trial data through CDMS or external data listings to ensure compliance with protocols.
Generate queries to resolve data discrepancies and support the development of CRFs and edit check specifications.
Maintain documentation related to CRF and data listing testing, including user acceptance testing.
Premier Research is a global clinical research, product development, and consulting company that helps biotech and specialty pharma transform life-changing ideas into new medical treatments. The company values teamwork, agility, and care for patients, providing a diverse culture with opportunities for growth and continuous learning.
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.
Perform on-site or remote pre-study, initiation, interim, and close-out monitoring visits to ensure adequate facilities and staff.
Identify investigators and verify qualifications, resources, and staff for conducting clinical studies.
Train investigational site staff and support regulatory submissions as applicable.
Ergomed is a specialist clinical research organization focused on rare disease and oncology trials. With a collaborative international team across North America, South America, Europe, Asia, and Australia, the company values teamwork, flexibility, and work-life balance.
Craft and review regulatory documents such as clinical study reports, protocols, and investigator's brochures.
Collaborate with a supportive team to exceed client expectations.
Learn the intricacies of drug development and the science behind pharmaceuticals and biologics.
Eldridge Writing is a growing firm providing top-tier medical writing services to pharmaceutical and biotechnology clients. They pride themselves on quality and mentorship of the next generation of medical writers.
Process external and local lab data throughout the clinical trial lifecycle using the elluminate platform.
Perform QC of laboratory normal ranges, test transfers, and data listings to ensure ICH/GCP and 21 CFR Part 11 compliance.
Collaborate with clinical data management and cross-functional teams to support study start-up, external vendor data transfers, and data quality.
eClinical Solutions helps life sciences organizations accelerate clinical development with expert data services and the elluminate Clinical Data Cloud. The company is a people-first, inclusive organization and a 2025 Top Workplaces USA Award winner for Remote Work.
Manage end-to-end IRB meeting workflows, including submissions, reviewer assignments, and meeting preparation.
Facilitate communication among client services, IRB Chairs, Board members, and clients to ensure timely review processes.
Prepare and review informed consent forms for regulatory compliance and quality.
The company coordinates Institutional Review Board (IRB) meetings within a highly regulated clinical research environment. They offer a collaborative and inclusive culture focused on ethical, patient-centered outcomes, though company size is not specified.
Monitor and own the progress of clinical studies at investigative sites, ensuring compliance with protocols and regulations.
Coordinate study setup activities, including investigator identification and regulatory submissions, while mentoring junior staff.
Interact directly with clients, manage payments, and participate in proposal activities, with travel up to 50-60%.
Precision for Medicine is a specialized CRO that combines agility with scientific expertise to support innovative clinical development programs. They foster a collaborative environment that values quality, accountability, and professional development, with a global team of experienced professionals.