Clinical Data Coordinator I
Caris Life Sciences
4 months ago
On-site
Boston, MA
Clinical Research and Development
Position Summary:
The Clinical Data Coordinator is responsible for clinical data entry activities for Caris Medical Affairs protocols and projects at Caris Precision Oncology Alliance sites. Ensures clinical data integrity and quality by collecting/reviewing clinical protocol research data, interpreting data (including appropriate source documentation) for computerized databases, understanding data definitions and case report forms, responding to queries in a timely fashion, and scheduling on-site visits for data review and EDC data entry.
Job Responsibilities:
- Abstract clinical data from subject source documentation.
- Enter clinical data into study-specific EDC case report forms.
- Clean clinical data to verify accuracy.
- Update EDC following verification, including resolution of data queries.
- Track site goals and case report form completion.
- Prioritize site cases for analysis.
- Maintain study-specific documentation.
- Perform QC audits of the clinical database.
- Support and adhere to GCP guidelines and comply with FDA, IRB, and HIPAA regulations, Site Operating Procedures, and ethical standards.
- Confirm appropriate consenting is performed and documented prior to data abstraction.
- Maintain Caris and site requirements for source document management and requests for information.
- Act as site designated entry person.
- Travel to multiple investigative sites if required.
- Communicate effectively with the research team, investigators, Clinical Research Associates, study sponsor, and ancillary staff.
Required Qualifications:
- 3–5 years of experience in data collection activities within a GCP/clinical research regulatory environment.
- Knowledge of critical clinical trial elements: GCPs, ICH, and Code of Federal Regulations.
- Oncology clinical study experience.
- Strong medical terminology understanding.
- Experience with small and large-scale project planning and reporting; strong communication and presentation skills.
- Experience training internal/external staff with a mentorship approach.
- Experience with EDC systems.
- Proficient in Microsoft Office Suite (Word, Excel, Outlook) and general working knowledge of Internet for business use.
Physical Demands:
- Ability to sit and/or stand for long periods.
Other:
- May require occasional evenings and overtime.
Conditions of Employment / Pre-Employment:
- Complete pre-employment process including criminal background check, drug screening, credit check (as applicable), and reference verification.
The Clinical Data Coordinator is responsible for clinical data entry activities for Caris Medical Affairs protocols and projects at Caris Precision Oncology Alliance sites. Ensures clinical data integrity and quality by collecting/reviewing clinical protocol research data, interpreting data (including appropriate source documentation) for computerized databases, understanding data definitions and case report forms, responding to queries in a timely fashion, and scheduling on-site visits for data review and EDC data entry.
Job Responsibilities:
- Abstract clinical data from subject source documentation.
- Enter clinical data into study-specific EDC case report forms.
- Clean clinical data to verify accuracy.
- Update EDC following verification, including resolution of data queries.
- Track site goals and case report form completion.
- Prioritize site cases for analysis.
- Maintain study-specific documentation.
- Perform QC audits of the clinical database.
- Support and adhere to GCP guidelines and comply with FDA, IRB, and HIPAA regulations, Site Operating Procedures, and ethical standards.
- Confirm appropriate consenting is performed and documented prior to data abstraction.
- Maintain Caris and site requirements for source document management and requests for information.
- Act as site designated entry person.
- Travel to multiple investigative sites if required.
- Communicate effectively with the research team, investigators, Clinical Research Associates, study sponsor, and ancillary staff.
Required Qualifications:
- 3–5 years of experience in data collection activities within a GCP/clinical research regulatory environment.
- Knowledge of critical clinical trial elements: GCPs, ICH, and Code of Federal Regulations.
- Oncology clinical study experience.
- Strong medical terminology understanding.
- Experience with small and large-scale project planning and reporting; strong communication and presentation skills.
- Experience training internal/external staff with a mentorship approach.
- Experience with EDC systems.
- Proficient in Microsoft Office Suite (Word, Excel, Outlook) and general working knowledge of Internet for business use.
Physical Demands:
- Ability to sit and/or stand for long periods.
Other:
- May require occasional evenings and overtime.
Conditions of Employment / Pre-Employment:
- Complete pre-employment process including criminal background check, drug screening, credit check (as applicable), and reference verification.