Sarah Cannon Research Institute (SCRI) needs to support the Study Coordinator to meet industry trial data deadlines and ensure all activities are conducted according to company standard operating procedures (SOPs) and all applicable Good Clinical Practice (GCP) and ICH regulations and guidelines to advance oncology treatments and improve outcomes for cancer patients.
Requirements
- Knowledge of scientific, medical, and regulatory terms
- Knowledge of GCP and Good Manufacturing Practice (GMP)
Responsibilities
- You will support the Study Coordinator to meet industry trial data deadlines
- You will obtain source documentation for patients enrolled into clinical trial
- You will assist the Study Coordinator with case report form completion and query resolution
- You will assist in Serious Adverse Event (SAE) reporting and tracking
- You will create and maintain patient visit tracking spreadsheets for the Study Coordinator
- You will maintain and archive study administrative files
- Throughout the conduct of the clinical trial you will assess adherence to SCRI SOPS, Good Clinical Practice (GCP) and ICH regulations and guidelines.
Other
- Detail-oriented
- Excellent English written and oral skills.
- Bachelor Degree preferred.
- Healthcare experience, Clinical trials support, or pharmaceutical industry experience preferred
