Retina Specialty Institute ยท 4 weeks ago
Clinical Trials Assistant
Retina Specialty Institute is a clinical research organization focused on ophthalmic studies. The Clinical Trials Assistant will support Clinical Research Coordinators with various study coordination tasks, ensuring compliance with Good Clinical Practice and assisting with documentation and communication related to clinical trials.
Health CareHealth DiagnosticsHospital
Responsibilities
Understands and adheres to Good Clinical Practice (GCP), U.S. Food and Drug Administration (FDA), and Institutional Review Boards (IRB) guidelines
Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
Assist with periodic review of study files for completeness
Assist CRCs with preparation, handling, and distribution of Clinical Trials Supplies and maintenance of tracking information
Assist with the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow
Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation
May accompany CRCs to assist with clinical monitoring duties upon completion of required training
Maintains security and confidentiality of patients and study-specific information per protocols and applicable federal regulations
Performs other required duties as requested by the Clinical Research Lead, Director, or Principal Investigator
Qualification
Required
High School Graduate or equivalent required
Current Good Clinical Practice certification required (must be obtained in the first 14 days after hire)
Experience As a Retina Or Ophthalmic Technician Required
Excellent interpersonal and communication skills (both verbal and written) required
Ability to adapt to multiple and rapidly changing priorities and deadlines
Work well under pressure and maintain a sense of urgency
Excellent organizational skills
Confident and capable communication with patients and coworkers
Handle Company business with the utmost professionalism, discretion, and tact
Friendly, helpful team player with a positive, customer-service attitude
Good collaboration and problem-solving skills
The ability to work independently and productively with little or no supervision
Dependable and reliable
Exercise good judgment and take initiative to properly address and resolve issues
Keep supervisor and coworkers informed of the status of issues and projects
Preferred
College Graduate preferred
Intermediate computer skills: Microsoft Word, Outlook and Excel preferred
Intermediate clerical skills: typing, data entry, filing, and record keeping