Clinical Research Assistant

Under the direct supervision of the Clinical Research Manager and the Principal Investigator (PI), the Research Assistant is responsible for the coordination and implementation of assigned research projects, data management, and communication of protocol activity within the Office of Research.

 

 

#CB

1. Coordination and Implementation of Study Activities
   1. Conducts recruitment, screening and enrolling of eligible patients into clinical trials.
   2. Explains protocol in detail and conducts informed consent procedure with potential research participants as deemed appropriate by the clinical research manager.
   3. Assists Clinical Research Manager to prepare for site visits and study initiation.
   4. Maintains complete working knowledge of all assigned protocols and reporting requirements.
   5. Maintains study-specific supplies and equipment.
   6. Collects study specimens according to protocol, processing, and preparation for shipping.
   7. Attends study meetings as requested by Clinical Research Manager and/or PI.
   8. Collaborates with Clinical Research Nurse and PI to manage study activities.
2. Data Management
   1. Collects, enters, and compiles clinical data required by protocol ensuring accuracy and timeliness of data entry.
   2. Maintains study files pertaining to clinical trials and completes source documents/case report forms.
3. Communication
   1. Communicates with Clinical Research Manager, PI, subjects, sponsor and other clinical trial personnel in a timely, efficient, and comprehensive manner.
   2. Communicates any adverse event, or protocol deviation to Clinical Research Manager and documents appropriately.
   3. Coordinates with Clinical Research Manager to identify procedures, laboratory tests, and protocol events that require consideration for financial, legal, and regulatory compliance.
   4. Collaborates with PI and Clinical Research Manager to develop materials and tools necessary to appropriately train key personnel in the protocol requirements, schedule of visits, and execution of clinical trial agreement.
4. Other Duties As Assigned
   1. Performs other duties as assigned or requested.

• 5 years research or healthcare related experience may be substituted for a Bachelor's degree.
• Bachelor's Degree
• Software applications, databases, spreadsheets, and word processing required. Excellent organizational skills required. Excellent attention to detail skills required. Must have ability to manage multiple and competing priorities. Must have oral and written communication skills. Must be able to work independently. Must be able to work with other professionals