VARITE INC ยท 5 days ago
Client Services Study Coordinator
VARITE INC is a company focused on client services in the clinical research field, and they are seeking a Client Services Study Coordinator. The role involves managing client relationships, overseeing clinical trial progress, and ensuring compliance with regulatory standards.
Information Technology & Services
Responsibilities
Point person for the facilitation of Clinical Trial Testing; bridges the sponsor and trial execution by managing client relationships and overseeing trial progress
Manage all aspects of assigned trials under your purview with direction from the lead Project Manager
Communicate with clinical and regulatory affairs and translate information effectively. This includes all matters; technical, facilitation of workflow, testing sites and customer relations
Maintain up to date and accurate logs reflecting testing status
Provide metrics to the site, customer or sponsor as requested
Resolve issues as they arise. Report critical issues to site leadership
Provide updates as requested
Develop SOPs supporting clinical trial testing as required
Maintain Study Binders/Trial Master File (TMF) as required per GCP
Perform Quality checks on all deliverables to customers. Partner with other employees to ensure second QC checks when required
Training other personnel as required
Qualification
Required
Associate or bachelor's degree (AA or BS)
Two years' experience and/or training in related field such as in a Contract Research Organization, University or Medical setting, or other equivalent experience
Experience working in regulated environments and familiarity with CAP/CLIA/CDx regulatory compliance and quality assurance standards
Minimum of 2 years Study Coordinator or Clinical Research or Trial experience required
Demonstrated proficiency in computer skills, such as word processing, Excel and information systems
Excellent verbal and written communication skills, customer service and problem-solving skills
Strong attention to detail and understanding of regulatory compliance, GCP and HIPAA
Knowledge of medical terminology
Positive attitude and the ability to adapt and be flexible in a fast-paced and evolving work environment
Organizational skillset, process driven, and able to manage multiple tasks with flexibility and ease