Talencio ยท 5 hours ago
Clinical Research Coordinator
Twin Cities Area
Contract
Onsite
New Grad, Entry LevelTalencio is a leading innovator specializing in minimally invasive solutions for oncology treatment. The Clinical Research Coordinator (CRC) assists in planning and executing clinical activities, supporting the clinical operations team by coordinating study activities and maintaining documentation standards.
ConsultingHuman ResourcesInformation TechnologyStaffing Agency
Responsibilities
Support clinical trials in collaboration with other clinical team members pertaining to site qualification, initiation, site management, data management and other ongoing tasks to support clinical trials
Perform study related activities in compliance with GCP and FDA regulations for clinical trials
Contribute to the formatting of study documents and manage the upload and tracking of clinical documents into the Quality Management System (QMS)
Ensure ordering of clinical study supplies when needed
Assemble and distribute study related documents including regulatory binders, case report form binders, study manuals, retention initiatives, and other study related tools to sites
Creation and maintenance of study trackers, dashboards, and reports
Support clinical study payments, where applicable
Participate in study-specific meetings, record meeting minutes including issues and actions items; and file minutes accordingly
Manage and track the electronic (and/or paper) study site and master files, ensuring audit readiness
Create and distribute study specific newsletters to the clinical sites
Provide travel and logistical support to physician proctors and clinical team as needed
Support the planning and conduct of investigator/study meetings
Ensure proper handling, accountability, and reconciliation of all Investigational Product (IP)
Assist with clinicaltrials.gov updates
Complete Central IRB submissions
Complete submission to the QMS
Organize and manage the Clinical Site email inbox
Facilitate licensing agreements with respective vendors
Facilitate document translations with respective vendors
Develop and maintain successful working relationships, manage deliverables, and provide feedback to cross functional team members
Qualification
Required
Excellent organizational skills
Excellent interpersonal, written, and verbal communication skills
Effectively build and maintain positive relationships with physicians, peers, and colleagues across all organizational levels
Ability to multitask effectively while maintaining high quality outputs
Preferred
Proven experience working within an FDA IDE pre-market clinical studies, post-market studies or registries
Strong knowledge and understanding of prostate anatomy
Company
Talencio
Talencio is recruiting agency and staffing firm that offers search services for executives, funding, and strategic partners.
Founded in 2008
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Paula Norbom
Founder & CEO
Company data provided by crunchbase