Independently conduct on-site and remote monitoring visits (SQVs, SIVs, IMVs, COVs) per protocols and regulations.
Manage site relationships, perform source data verification and review, and resolve data discrepancies.
Track monitoring findings, escalate risks, and maintain inspection-ready documentation.
Karius is a venture-backed life science company focused on clinical metagenomics, using genomics and AI to detect infectious diseases from microbial DNA in blood. The company is dedicated to advancing diagnostic science and improving patient care.
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.
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.
Lead the development and optimization of clinical data systems across global trials.
Drive data standardization and build scalable validation frameworks to ensure data integrity.
Act as a strategic liaison between clinical, biostatistics, and regulatory teams to translate requirements into technical solutions.
Precision Medicine Group is a global life sciences company focused on precision medicine and clinical research solutions. The company fosters a collaborative and compliance-oriented culture with a diverse team of professionals.
Produce business and market intelligence by querying data repositories and generating periodic reports to identify patterns and trends.
Clean, transform, and analyze data to create key business insights and support recommendations for action.
Manage raw data, create databases, and analyze data using statistical methods to present clear summaries.
WCG delivers transformational solutions that accelerate clinical research and advance human health. They serve experts on the frontlines of science and medicine, investing in their people with comprehensive benefits and career development opportunities.
Create and maintain Study Trackers and monitor screening deadlines.
Review study visits and sweeps for readiness using page status and query reports.
Monitor review progress, identify issues and risks, and report to Lead Central Review Manager.
ICON is a global healthcare intelligence and clinical research organization that accelerates drug development. It is a large, values-driven organization with a focus on integrity, collaboration, agility, and inclusion.
Complete the CRA Training Program (12-14 weeks) to gain the skills needed as a primary CRA.
Conduct site visits (PSSV, SIV, IMV, COV) and manage site performance, data quality, and patient safety.
Build strong relationships with site personnel and ensure effective communication with the Clinical Study Team.
BeOne is a global oncology company discovering and developing innovative, affordable treatments for cancer patients worldwide. Our growing global team of more than 11,000 colleagues fosters a collaborative, patients-first culture.
Lead clinical data risk management and central monitoring across multiple clinical studies.
Evaluate clinical trial data to identify risks, trends, and emerging issues affecting study outcomes.
Develop key risk indicators and analytical approaches to support risk-based quality management.
Jobgether is an AI-powered job matching platform that connects candidates with hiring companies. They operate globally but focus on efficient and fair candidate review processes.
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.
Manage Investigator sites and conduct on-site and centralized monitoring visits to ensure subject safety and data integrity.
Collaborate with cross-functional teams and external partners to maintain quality study oversight from start-up through close-out.
Support development of study documents, maintain TMF, and ensure inspection readiness while embodying core company values.
MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. The company combines cutting-edge technologies like optogenetics and spatial transcriptomics to identify novel drug targets, with a culture of integrity, collaboration, bravery, and dedication.
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.
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.
Apply specialized clinical knowledge to categorize, code, and interpret registry data from patient medical records.
Ensure quality submission of data in specified registries, maintaining high accuracy standards.
Prioritize tasks, meet tight deadlines, and troubleshoot technical issues with EMR systems.
Q-Centrix partners with hospitals to deliver quality clinical data solutions, specializing in cancer registry and data abstraction. With a remote-first culture and employee-centric leadership, the company has earned the Great Place to Work distinction multiple years.
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.
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.
Drive cross-functional collaboration and track progress using project management tools to ensure on-time delivery of objectives.
Conduct audits of call and email communications to assess quality and accuracy, compiling feedback summaries for management.
Support patient-focused teams with quality improvement initiatives and maintain documentation such as SOPs and protocols.
Natera is a global leader in cell-free DNA testing for oncology, women's health, and organ health. The team consists of highly dedicated statisticians, geneticists, doctors, and other professionals from world-class institutions, fostering a culture of hard work and growth.
Ensure the highest standards of patient safety and data integrity at clinical research sites through regular quality assurance reviews.
Execute the yearly corporate audit plan, tracking audits and preparing detailed outcome reports for management.
Provide ongoing guidance and best-practice recommendations to site personnel and clinical project teams.
Care Access is a clinical research company that brings world-class research and health services directly to communities. With hundreds of research locations and clinicians globally, they are dedicated to ensuring every person has the opportunity to understand their health and contribute to medical breakthroughs.
Support project Data Manager to deliver high-quality results within timelines, taking ownership and communicating status.
Apply adjudication guidelines to ensure compliance, using judgment to address variations and escalate complex issues.
Serve as operational contact for committee members, prepare meeting agendas, and manage study inbox for external communications.
WCG delivers transformational solutions that accelerate clinical research and advance human health. They invest in their employees, offering comprehensive benefits and career development opportunities in a supportive culture.
Independently manage ICSR triage, case processing, and quality control for global safety reports.
Perform SAE reconciliation between safety and clinical databases, ensuring compliance with timelines.
Support team development through training, onboarding, and process improvement initiatives.
This company is a partner organization focused on global pharmacovigilance operations. It is a fast-growing, internationally focused company with a collaborative culture emphasizing teamwork, excellence, and continuous improvement.