Description
We are seeking a Clinical Research Coordinator to assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems.
Responsibilities:
- Assist CRAs and RSU team with updating and maintaining clinical documents and systems, such as Trial Master File (TMF)
- Prepare, handle, distribute, file, and archive clinical documentation and reports
- Review study files for completeness
- Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies
- Track and manage Case Report Forms (CRFs), queries and clinical data flow
- Act as a central contact for the clinical team for designated project communications
- May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training
Qualifications:
- Bachelor's Degree Required
- 3 years administrative support experience
- Equivalent combination of education, training and experience
- Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint
- Written and verbal communication skills including good command of English language
- Effective time management and organizational skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients
- Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Knowledge of applicable protocol requirements
The potential base pay range for this role, when annualized, is $35,800.00 - $123,000.00.