Data Coordinator
About The Position
The Data Coordinator provides support to the Study Coordinator on a daily basis, ensuring all activities are conducted according to company standard operating procedures (SOPs) and all applicable Good Clinical Practice (GCP) and ICH regulations and guidelines. This role involves supporting the Study Coordinator to meet industry trial data deadlines, obtaining source documentation for patients enrolled into clinical trials, assisting with case report form completion and query resolution, and aiding in Serious Adverse Event (SAE) reporting and tracking. The Data Coordinator will also create and maintain patient visit tracking spreadsheets, maintain and archive study administrative files, and be assigned special procedural projects to enhance the functioning of Drug Development Data Operations. Throughout the conduct of the clinical trial, the Data Coordinator will assess adherence to SCRI SOPs, Good Clinical Practice (GCP), and ICH regulations and guidelines.
Requirements
- Knowledge of scientific, medical, and regulatory terms
- Knowledge of GCP and Good Manufacturing Practice (GMP)
- Detail-oriented
- Excellent English written and oral skills
Nice To Haves
- Bachelor Degree preferred
- Healthcare experience
- Clinical trials support
- Pharmaceutical industry experience preferred
Responsibilities
- Support the Study Coordinator to meet industry trial data deadlines
- Obtain source documentation for patients enrolled into clinical trial
- Assist the Study Coordinator with case report form completion and query resolution
- Assist in Serious Adverse Event (SAE) reporting and tracking
- Create and maintain patient visit tracking spreadsheets for the Study Coordinator
- Maintain and archive study administrative files
- Be assigned special procedural projects to enhance the functioning of Drug Development Data Operations
- Assess adherence to SCRI SOPs, Good Clinical Practice (GCP) and ICH regulations and guidelines throughout the conduct of the clinical trial
Benefits
- Comprehensive benefits to support physical, mental, and financial well-being
- Competitive compensation package
- Annual bonus or long-term incentive opportunities may be offered
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
