Data Coordinator
About The Position
The Data Coordinator provides support to the Clinical Research Coordinator (CRC) and Research Nurse on a daily basis, ensures all activities are conducted according to company standard operating procedures (SOPs) and all applicable Good Clinical Practice (GCP) and ICH regulations and guidelines. You will support CRC to meet industry trial data deadlines. You will obtain source documentation for patients enrolled onto clinical trials. You will assist CRC with case report form completion and with query resolution. You will assist in Serious Adverse Event (SAE) reporting and tracking. You will create and maintain patient visit tracking spreadsheets for CTS. You will maintain and archive study administrative files. You will maintain and archive regulatory files. You will assist in ensuring source document templates are accurate. You will be assigned special procedural projects to enhance the functioning of the research program. Throughout the conduct of the clinical trial you 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 CRC to meet industry trial data deadlines
- Obtain source documentation for patients enrolled onto clinical trials
- Assist CRC with case report form completion and with query resolution
- Assist in Serious Adverse Event (SAE) reporting and tracking
- Create and maintain patient visit tracking spreadsheets for CTS
- Maintain and archive study administrative files
- Maintain and archive regulatory files
- Assist in ensuring source document templates are accurate
- Be assigned special procedural projects to enhance the functioning of the research program
- 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
