Perform review and analysis of centralized data to identify signals and trends in predefined risk indicators.
Support initial review of Risk Assessment and Categorization Tool (RACT) and conduct periodic reviews of site-level Key Risk Indicators (KRIs).
Monitor site performance, evaluate quality and integrity of study practices, and maintain effective project communication on centralized monitoring findings.
Ergomed is a specialist clinical research organization focused on rare disease and oncology trials, partnering with small to midsize biotech companies to move therapies through early phase development. With a collaborative international team across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility, and work-life balance, fostering a culture where employees take ownership and grow their careers.
Perform on-site or remote Pre-Study, Initiation, Interim, and Close-Out monitoring visits to ensure sites are adequate for study conduct.
Verify investigator qualifications, resources, facilities, equipment, and staff for clinical study conduct.
Train site staff, support regulatory/EC submissions, and mentor junior staff during co-monitoring visits.
Ergomed Group is a global clinical research organization helping biopharmaceutical companies develop and deliver therapies in oncology, rare disease and other complex areas. Its diverse teams across countries and time zones collaborate with kindness, curiosity and a shared sense of purpose.
Lead research efforts on complex care cases, including reviewing medical records and clinical history.
Identify and evaluate diagnostic and treatment options, including clinical trials and innovative therapies.
Communicate research findings to clients and clinicians to support shared decision-making.
Private Health Management is a healthcare navigation firm that assists clients with serious and complex medical conditions. The company operates remotely across the United States with a team of compassionate, dedicated professionals focused on precision medicine.
Prepare, conduct, and report on all types of monitoring visits.
Ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements.
Perform source data verification and manage site-level risks.
PSI is a leading Contract Research Organization with 30 years in the industry, offering a perfect balance of stability and innovation to clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Partner with cross-functional teams and study sites to support clinical operations across all trial phases.
Perform remote monitoring of clinical trials and serve as secondary contact for sites supporting CRAs.
Ensure proper reporting and follow-up of SAEs, address non-compliance issues, and assist with audit/inspection readiness.
Premier Research is a global clinical research, product development, and consulting company helping biotech, specialty pharma, and MedTech innovators turn breakthroughs into new treatments. The company fosters a collaborative culture focused on agility, continuous learning, and making an impact.
Monitor clinical studies at investigative sites to ensure compliance with protocols, SOPs, and ICH-GCP.
Coordinate study setup and initiation activities, including investigator identification and regulatory submissions.
Identify study risks and propose mitigation strategies while maintaining high quality and detail.
Precision for Medicine is a CRO integrating clinical trial execution with scientific expertise and data sciences, focusing on Oncology and Rare Disease. It offers a supportive, small-CRO culture with high CRA retention and emphasis on work-life balance.
Conduct and report all types of onsite monitoring visits and be involved in study startup.
Perform CRF review, source document verification, and query resolution while managing site communication.
Support regulatory team in preparing documents and participate in feasibility research.
PSI is a leading Contract Research Organization with 30 years in the industry, offering a balance between stability and innovation to clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.