Serve as primary contact for assigned study sites, ensuring protocol implementation and compliance with ICH-GCP and local regulations.
Conduct on-site and remote monitoring visits, building strong relationships with site staff and resolving operational issues.
Maintain inspection readiness of sites, manage study documentation, and contribute to study performance tracking and recruitment support.
Our partner is a clinical research organization that manages global clinical trials. They offer a collaborative global team environment and opportunities for career development in clinical operations.
Conduct qualification, initiation, interim, and close-out monitoring visits (on-site and remote) in compliance with GCP, ICH, and SOPs.
Build and maintain strong relationships with investigator sites, providing training and guidance to ensure study quality.
Support IRB submissions, regulatory documentation, and trial master file quality across clinical programs.
CoMind develops non-invasive neuromonitoring technology for clinical brain monitoring. The company is a cutting-edge startup focused on improving diagnosis and treatment of brain disorders, with a culture that embraces AI in daily work.
Perform ongoing clinical data review to ensure data quality, consistency, and completeness.
Identify discrepancies and raise/resolve queries in EDC systems.
Review patient data including eligibility, medical history, treatment, safety data, and outcomes.
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. They partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity and anticipate change.
Monitor and interpret CMS guidance for Medicare, Medicaid, and other healthcare programs.
Partner with internal teams to ensure compliance with regulations and contract obligations.
Maintain regulatory tracking documentation and support development of training materials.
HealthEdge provides healthcare software and services to payers and providers. It is a growing company with a focus on compliance and innovation, fostering a collaborative and remote-friendly culture.
Serve as the primary liaison for investigator sites, conducting monitoring activities including initiation, routine visits, and close-out while ensuring ICH-GCP compliance.
Support site activation, recruitment, and enrollment, oversee adverse event reporting, and maintain accurate study documentation.
Manage investigational product handling, develop corrective actions for site issues, and participate in audit readiness activities.
Jobgether is a platform that uses AI-powered matching to connect candidates with clinical research roles. The company evaluates applications objectively and shares top candidates with hiring partners, focusing on improving patient access to innovative therapies.
Prepare and submit regulatory documents to IRBs/ECs and support study start-up activities.
Perform data entry, document cleanup, and QC during migration to Florence eRegulatory.
Maintain CVs, licenses, and GCP documentation, partnering with coordinators, investigators, and sponsors.
UniTriTeam is a global organization that supports clinical research sites and organizations through staff augmentation and technology solutions. They pride themselves on creating opportunities for their team members while delivering exceptional results for their clients.
Supports all phases of clinical development and execution.
Ensures high quality data by being the study protocol expert and key site resource for questions.
Maintains and tracks clinical study data and supports investigator qualification selection.
SI-BONE is a medical device company focused on minimally invasive sacropelvic solutions. They aim to help patients with sacroiliac pelvic conditions and have provided over 90,000 procedures to date using their iFuse Implant System.
Provide operational oversight and support for multiple clinical research sites within the network.
Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, and sponsor protocols.
Build and maintain strong working relationships with Sponsors, CROs, and external partners.
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. They leverage convenient, trusted healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs.