Perform all aspects of clinical site monitoring, including routine, initiation, and close-out visits.
Ensure patient safety and data integrity by verifying informed consent and protocol adherence.
Manage site communications, complete SAE reporting, and assist with new employee training.
Fortrea is a clinical research organization that helps biopharmaceutical and medical device companies bring life-saving therapies to patients. The company emphasizes a collaborative, family-oriented culture with a focus on teamwork and excellence, employing a large workforce globally.
Support the Associate Director in managing day-to-day operations of the External Audit Program, ensuring alignment with program goals and regulatory timelines.
Serve as a versatile operational resource across workstreams, identifying process improvements and implementing changes to enhance scalability, transparency, and quality.
Communicate updates, risks, and recommendations clearly to cross-functional stakeholders, and support AI-native monitoring of program-wide KPIs.
Devoted Health is on a mission to improve the health and well-being of older Americans through an integrated care platform combining data and AI with clinical and service experiences. The company is an equal opportunity employer that values diversity and collaboration, with a team dedicated to a supportive work environment.
Lead a team of Operational Controls Analysts to execute monitoring strategies across patient support programs.
Ensure consistent application of control frameworks and manage monitoring volume based on operational risk.
Develop analysts through coaching, performance management, and cross-training while enforcing governance boundaries.
Novartis is a healthcare and life sciences company focused on improving the lives of people living with disease through innovative science. The company is a large global organization committed to a community-driven approach, with a culture of learning and collaboration.
Provide strategic and operational leadership for Immunome's clinical trial monitoring function, including implementing contract field monitoring team and standardizing monitoring strategy across the oncology portfolio.
Lead and develop a high-performing field monitoring function, partnering closely with Clinical Site and Trial Operations, Data Management, and Quality to ensure data quality and patient safety.
Manage monitoring budgets, resources, and vendor oversight, ensuring compliance with ICH-GCP, FDA, EMA regulations and driving inspection readiness.
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. They have a leadership team experienced in design, development, and commercialization of cutting-edge therapies including antibody-drug conjugates.
Monitor and evaluate telephone and electronic interactions for adverse events, product quality complaints, and medical information requests to ensure compliance with regulatory and client standards.
Identify quality and performance trends and partner with leadership to provide coaching, feedback, and training for continuous improvement.
Compile and report QA metrics, support internal and client audits, and maintain confidentiality of sensitive information.
Inizio Engage is a healthcare services company specializing in medical information, pharmacovigilance, and patient support programs. The company is part of a global organization and is committed to providing equal employment opportunities and fostering a diverse and inclusive workplace.
Support the Engagement Center Operations team with day-to-day operations, new site implementations, and strategic initiatives.
Organize and maintain documentation such as workflows, action plans, and KPI reports to enable operational success.
Assist with performance metric tracking, audit processes, and troubleshooting growth opportunities.
Shields Health Solutions partners with health systems to improve patient care through specialty pharmacy services. The company fosters a collaborative, data-driven culture with a close-knit team.
Independently conduct and document onsite and remote monitoring visits, ensuring protocol and regulatory compliance.
Serve as primary liaison between sponsor and investigative sites, managing data queries and site communications.
Mentor junior CRAs and participate in audits, inspections, and process improvement initiatives.
Alimentiv is a clinical research organization that provides clinical trial monitoring and site management services. The company fosters a dynamic, results-driven, and high-accountability environment with a focus on quality and compliance.
Oversee outsourced Medical Information Contact Center vendor, managing performance, governance, and compliance for medical inquiries, adverse event intake, and product quality complaints.
Partner with internal teams to integrate contact center workflows with Medical Affairs, Pharmacovigilance, and IT systems, ensuring seamless data transfer and regulatory adherence.
Ensure all operations are inspection-ready, maintain procedural documents, and deliver performance reporting to leadership.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. The company is headquartered in Radnor, Pennsylvania, and operates as a fully remote organization with a collaborative culture.
Provide stakeholder management, requirements gathering, and data integrity support for clinical informatics projects.
Profile data and monitor data-quality metrics using dashboards in Microsoft Purview, aligning with VA privacy, HIPAA, and FISMA requirements.
Support interoperability, data integrity, and reporting by managing data feeds and performing requirements analysis for improvements.
Aptive partners with federal agencies to achieve their missions through improved performance, streamlined operations and enhanced service delivery. Founded in 2012, the company employs over 300 people nationwide and focuses on applying technology, creativity, and human-centered services.
Own end-to-end operating model and outcomes for provider engagement and growth programs, ensuring timelines, milestones, and intended results are met.
Track program performance through data, translate into concise reports for senior leadership, and provide recommendations for prioritization.
Collaborate with cross-functional teams and engage directly with providers and practice staff to maintain momentum and drive program success.
Counterpart Health transforms healthcare with an AI-enabled primary care tool, Counterpart Assistant, that supports earlier diagnosis and management of chronic conditions. As a subsidiary of Clover Health, they have a remote-first culture with a focus on diversity and inclusion, and thousands of practitioners using their tool.
Conduct compliance reviews, audits, and risk assessments using established frameworks.
Assist with investigations by gathering evidence, conducting interviews, and documenting findings.
Track corrective actions and support institutional audit readiness efforts.
Nightingale Education Group is a nursing school focused on closing health equity gaps by building a skilled nursing workforce. They have graduated nearly 5,000 nurses and emphasize a growth mindset, transparency, and personal accountability.
Investigate complex credit reporting disputes and SCRA determinations, bringing stakeholders together for broader input.
Translate new state legislation into actionable compliance guidance and lead quarterly monitoring and testing.
Serve as subject matter expert on consumer protection laws, shaping policies and controls as the company scales.
Reprise Financial simplifies personal loans, making them accessible and transparent with loans up to $25,000. The company values innovation and collaboration, providing tools and support for employees in a customer-focused environment.
Lead global transparency operations, customer delivery, and managed services to ensure accurate, timely, and compliant regulatory reporting.
Build executive relationships with compliance, legal, and finance leaders in life sciences, driving strategic client engagement and retention.
Partner with product, engineering, and sales to prioritize product enhancements and improve customer experience and operational efficiency.
MediSpend provides global transparency solutions and managed services for life sciences companies, ensuring compliant regulatory reporting. The company is a software and services provider with a focus on operational excellence, fostering a culture of accountability, collaboration, and innovation.
Support compliance monitoring, investigations, and audits to ensure adherence to TEFCA, HIPAA, and information blocking regulations.
Utilize Databricks, SQL, and AI tools to analyze data exchange activity and prepare compliance reports and dashboards.
Collaborate with Legal, Security, and Engineering teams to develop policies, maintain compliance documentation, and foster regulatory excellence.
Health Gorilla is a national interoperability and health information exchange company dedicated to improving healthcare through secure, standards-based data sharing. As a designated Qualified Health Information Network (QHIN) under TEFCA, it connects healthcare organizations nationwide and operates as a growth-stage company with a collaborative, compliance-focused culture.
Examine and evaluate financial, operational, compliance, technical, and program activities to assess effectiveness and identify risks.
Plan, conduct, and report on internal audits and consulting engagements across Lottery departments.
Utilize data analytics software to measure performance, highlight trends, and draw conclusions from large transaction volumes.
The Oregon Lottery is a leader in the gaming industry, contributing revenue for Oregon's schools, economic development, and other programs. The organization values fairness, integrity, and a culture of safety, with a focus on diversity and equity.
Own and lead execution of Field Reimbursement readiness priorities, translating organizational objectives into scalable field capabilities.
Oversee operational performance, identify systemic gaps, and implement improvements to enhance efficiency.
Support deployment and maintenance of reporting aligned to predefined KPIs and partner with Analytics for accurate reporting.
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. The company has been recognized for its award-winning culture, including being a Great Place to Work in 2021.
Coordinate operational activities to support commercial and government accounts, including pricing updates and workflow tracking.
Partner with cross-functional teams to maintain accurate records and ensure timely completion of milestones.
Maintain Salesforce CRM data accuracy and prepare reports on pipeline activity and pricing updates.
FUJIFILM Healthcare Americas Corporation provides cutting-edge healthcare solutions including diagnostic imaging and in-vitro diagnostics. With over 70,000 employees globally, the company fosters a dynamic, flexible environment that fuels creativity and collaboration.
Monitor and oversee progress of clinical studies at investigative sites, ensuring compliance with protocols, SOPs, ICH-GCP, and regulations.
Coordinate study setup and monitoring activities, including investigator identification, regulatory submissions, and site initiation visits.
Identify potential study risks and propose solutions, while maintaining an impeccable eye for detail and quality outcomes.
Precision for Medicine, Oncology and Rare Disease is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, and advanced biomarker and data analytics. They pride themselves on high CRA retention rates and a culture where employees feel appreciated and have impact.
Coordinate MZLA’s privacy and compliance program work, including planning, recurring reviews, risk tracking, documentation, and leadership reporting.
Translate privacy, security, and compliance requirements into practical processes that fit how MZLA works.
Coordinate vendor and tool reviews with legal, engineering, product, support, finance, operations, and other stakeholders.
Thunderbird is a trusted open-source email application used by over 20 million people. MZLA, the team behind Thunderbird, is a small but growing company of 60+ employees across seven countries, focused on building privacy-respecting communication and productivity tools.
Own the end-to-end retailer onboarding process, from contract through go-live, coordinating with engineering and customer success.
Manage weekly scan data submission health, publish dashboards, and ensure timely issue resolution with retailers and CPG partners.
Serve as primary contact for Altria and RJR, handling compliance, issue remediation, and cross-functional coordination.
PAR Technology Corporation is a leader in restaurant technology, providing software and hardware solutions to over 100,000 restaurants in more than 110 countries. The company embraces a 'Better Together' ethos, offering Unified Customer Experience solutions.