Talencio · 1 day ago
Senior Clinical Research Associate - CONTRACT
Twin Cities Area
Contract
Hybrid
Senior Level, Lead/Staff
8+ years expTalencio is an innovative medical device company specializing in active implantable solutions. They are seeking a Senior Clinical Research Associate to support high-quality clinical activities, including study startup, regulatory documentation, and compliance with FDA and GCP standards.
ConsultingHuman ResourcesInformation TechnologyStaffing Agency
Responsibilities
Coordinate clinical trial site activities, including site selection, qualification, and initiation, ensuring compliance with regulatory requirements and GCP
Oversee study startup activities such as IRB submissions, informed consent form customization, and collection of site regulatory documentation
Serve as the primary point of contact for clinical sites during startup to facilitate documentation, training, and communication
Collaborate with site personnel to ensure timely completion of startup deliverables, including regulatory compliance and investigator training
Assist in the development of study-related materials, including case report forms, study manuals, monitoring plans, and investigator meeting content
Facilitate resolution of data discrepancies and assist with query management during the study lifecycle
Monitor IRB requirements and site compliance to ensure timely approvals and adherence to study protocols
Track and report study progress metrics, including site activation and patient enrollment
Conduct pre-study, initiation, routine, and close-out visits as needed to ensure protocol adherence
Qualification
Required
Bachelor's degree in a medical, scientific, or related field
Minimum of 8+ years of experience in medical device clinical research
Proven expertise in study startup activities, including site selection, regulatory submissions, and site training
Knowledge of FDA regulations, ICH/GCP guidelines, and ISO standards, with specific experience in Class II or III devices
Excellent written and verbal communication skills, with the ability to build relationships with site personnel and investigators
Strong organizational and multitasking abilities to manage multiple sites and deadlines in a fast-paced environment
Ability to travel up to 40%, based on study needs
Preferred
Experience with FDA IDE pre-market clinical studies preferred
Experience in cardiology, neuromodulation, or urology is highly desirable
Company
Talencio
Talencio is recruiting agency and staffing firm that offers search services for executives, funding, and strategic partners.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Paula Norbom
Founder & CEO
Company data provided by crunchbase