Clinical Research Specialist

Monument Health Rapid City Hospital•Rapid City, SD

19h•Onsite

About The Position

Clinical Research Specialist is responsible for working in collaboration with the Clinical Research team and performing established clinical support for the conduct of clinical research trials. Working under the direction from leadership and the Clinical Research Coordinators to develop, implement and continue evolution of systems that ensure adherence to research protocols, institutional policies, local/state/federal regulations and “Good Clinical Practice.” Establish and maintain effective working relationships with team members, extended Healthcare providers, clinical research organizations, and regulatory agencies to ensure the safe and effective care of those who volunteer to be participants in clinical research.

Requirements

High School Diploma/GED Equivalent
1+ years of Clinical Research Experience
Requires the ability to work assigned schedules and hours as determined by the department

Nice To Haves

Associates degree in Health Related Field
Human Subject Protection (HSP) - Collaborative Institutional Training Initiative (CITI); and Good Clinical Practice (GCP) - Collaborative Institutional Training Initiative (CITI)

Responsibilities

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.