Data Compliance Coordinator
at Thermo Fisher Scientific
Praha, Praha, Czech -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 29 Jul, 2024 | Not Specified | 01 May, 2024 | N/A | Time Management | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
TO BE CONSIDERED FOR THIS EXCITING OPPORTUNITY YOU WILL REQUIRE THE FOLLOWING SKILLS AND EXPERIENCE:
- Good time management and multitasking skills in order to coordinate several studies with a number of participants simultaneously
- Appropriate MS Office Skills
- Good attention to detail
Responsibilities:
KEY RESPONSIBILITIES FOR A DATA COMPLIANCE COORDINATOR ARE AS FOLLOWS:
- Coordinates operational compliance activities on one or more studies to ensure successful delivery of the studies.
- Ensures accurate and timely entry of all data in the CRF from the source notes, and tracks the flow of the CRF’s, queries, and patient recruitment statuses; reports out the flow of data.
- Maintains ISF and study trackers as delegated.
- Follows the QC process and checks that ICF’s are correctly completed.
- Ensures that protocol visit windows are scheduled according to the protocol requirements and reports deviations.
- QCs all supporting reports (laboratory reports/GP SDV/Consultant) to ensure they are reviewed and signed off by a physician within the appropriate timelines and flags any out of range values.
- Assist with archiving procedures if required.
- Assists monitors, sponsor representatives with the preparation of monitoring visits and query resolutions during monitoring visits.
- Identifies quality issues (QI) and to reports them, and applies CAPA reporting and root cause analyses.
- Prepares and collates regulatory documents for submission.
- Interprets and adheres to company SOP and COP, and assists with input during the review process.
- Adheres to the rules and regulations of ICH, GCP and other regulatory and ethical guidelines and data protection regulations.
- Assists with drafting compliance reports.
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
Praha, Czech