As a Research Support Assistant, you will provide clerical support to Clinical Research Associate, Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Research Manager. This role will provide the administrative support for research protocols by providing document management, obtaining proper signatures, and maintaining samples, kits, and study supplies. This role will comply with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Essential job duties and responsibilities:
- Provides clerical support to Clinical Research Associate, Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Research Manager.
- Will complete data entry as required.
- Provides document management for research activities.
- Handles the process of obtaining the proper signatures for research grants and protocols.
- Provides administrative support for research protocols.
- Completes sample preparation and shipping and maintains study supplies and kits.
- Responsible for obtaining outside research records for patients enrolled in protocols.
- Schedules research meetings.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- Participates in required training and education programs.
Department and/or unit specific responsibilities:
- Manages filing system for research subject charts.
- Organizes agenda and takes minutes and clinical research meetings.
- Enters data into REDCap and other electronic data captures systems.
- Assists with creating source documentation forms for investigator-initiated studies.
- HS graduate or equivalent
- Previous coursework and experience in related field
- Must be computer literate
- Able to perform moderate lifting
- Able to sit, stand and walk for prolonged periods of time
- Able to read papers and online documents
- Able to operate standard office equipment
- Able to exercise physical ability and perspective acuity to satisfactorily perform essential job function
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