Upsilon Global · 2 weeks ago
Senior Clinical Research Associate
United States
Contract
Remote
Senior Level
5+ years expUpsilon Global is seeking a freelance Senior Clinical Research Associate based in the south central America area to provide regionalized monitoring for studies focused on NASH and renal hepatology. The role involves conducting on-site visits, ensuring adherence to study protocols and regulatory requirements, and collaborating with site staff to ensure successful execution of clinical trials.
AdviceConsultingRecruiting
Hiring Manager
Lina Cruz
Responsibilities
Conduct on-site visits, monitoring and assessment of clinical trial site, ensuring adherence to study protocols, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements
Perform source document verification, data collection, and accurate recording of study data, ensuring data integrity and compliance
Collaborate with site investigators, site staff, and study team members to ensure successful execution of clinical trials
Assist in the development and review of study documents, including protocols, informed consent forms, and case report forms
Maintain effective communication with study site, sponsors, and other stakeholders to provide timely updates, address queries, and resolve issues
Monitor subject safety, reporting adverse events, and ensuring appropriate follow-up actions are taken
Contribute to the preparation and coordination of study initiation, monitoring, and close-out activities
Assist in the preparation and participation in regulatory inspections and audits as necessary
Stay updated with current regulations, guidelines, and industry trends related to clinical research in translational/early-phase trials
Qualification
Required
5+ years independent monitoring experience
Experience in liver and kidney diseases essential
A strong background in early-phase / phase I/II trials
In-depth knowledge of U.S. regulatory requirements and clinical trial processes
Strong organizational and communication skills, with the ability to manage multiple priorities
Ability to work independently, demonstrating initiative, attention to detail, and problem-solving skills
Willingness to travel across the South central America
Company
Upsilon Global
Upsilon Global provides consulting and advice services for the clinical research industry.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase