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Job CategoryEducation and Research
Scheduled Weekly Hours40
Job SummaryThe Clinical Research Assistant is responsible for working in collaboration with the Clinical Research Team to conduct general trial functions including but not limited to: implementation, coordination, enrollment, follow-up, regulatory and data collection duties.
- Assimilate and dispense study-related training materials and periodic communications to pertinent team members.
- Creates and maintains a database of all past and present research patients and all open and closed protocols.
- 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.
- Creates and maintains filing and record systems for the research department. This includes protocol folders, departmental records, personnel rosters for NCCTG and other affiliated groups and resource manuals for these groups.
- Composes routine correspondence and other documents such as letters, memorandums, policies, and reports.
- 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 effective perform their job, assisting them while on site, close-out visit with investigator, addressing action items in monitoring letter.
- Functions as liaison between clinical research investigators and various organizations/departments/agencies including but not limited to: Institutional Review Board, FDA, Grants Management, Clinical Research Departments, Patient Business Services, and sponsor/monitors.
- The Clinical Research Assistant is responsible for working in collaboration with the Clinical Research Coordinators and the extended research team to conduct general trial implementation, coordination, enrollment, follow-up, and data collection duties.
- Works with Clinical Research Department and colleagues to prioritize projects and activities in order to ensure optimal allocation of research coordinator resources.
- All other duties as assigned.
Education - High School Diploma/GED Equivalent in General Studies
Experience - 1+ years of Clinical Research Experience; 1+ years of Healthcare Experience
Light work - Exerting up to 20 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.10 Monument Health Rapid City Hospital, Inc.
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