Clinical Research Specialist

• Assist lead CRC in developing source document templates in Microsoft Word, Excel, or similar program. Source documents should be routinely maintained to reflect accurate information that is required of sponsors by verifying against eCRF software.
• Completes relevant data collection, entry and analysis as and when needed.
• Coordinates the efforts of case finding and recruitment of study patients.
• Create, organize, submit, and maintain all pertinent study documents, records, and logs from start-up to study closure between sponsor and other offices. Documents would include regulatory documents, contracts, temperature logs, budgets, licenses, training documentation, etc.
• Creates and maintains study and subject specific case report forms. Develop data collection worksheets that ensure complete collection of data which can be accurately transmitted by data entry staff.
• Demonstrates the ability to work in collaboration with other members of the Clinical Research Team to provide safe quality care to our subject population and efficiently complete daily responsibilities which include the following:
• Develop documents and processes for successful trial implementation which are consistent with internal processes and procedures, regulatory requirements, and “Good Clinical Practice.”
• Facilitate site monitoring visits by assuring they have all the information and materials needed to effectively perform their job, assisting them while on site, close-out visit with investigator, addressing action items in monitoring letter.
• Follows study protocol in scheduling of tests, procedures, and administration of medications.
• Implement effective study-specific screening, enrollment, and follow-up processes.
• All other duties as assigned.

Monument Health