Description
Job Purpose:The Clinical Safety Associate II (CSA II) for LEAD-gRED supports the early development safety and risk management activities within the gRED organization as part of the LEAD-gRED early development safety science organization. This position is focused on supporting the safety-related operational activities on the early development teams. Responsibilities are performed under the direction of the Principal Safety Scientist.
Job Duties/Responsibilities:
- Demonstrates advanced knowledge of safety reporting concepts, focused on standards set out in ICH and FDA guidelines for drug safety reporting requirements.
- Demonstrates knowledge of requirements of clinical trial processes including CRO management, investigator and site training needs with respect to safety reporting, and safety data exchange agreements (SDEA).
- Acts as single point of contact for CROs and affiliates with respect to safety operations activities.
- Assists gRED Clinical Operations with ensuring appropriate inclusion of safety reporting information for investigator and site training.
- Independently performs clinical trial reconciliation (as applicable).
- Review and address deviations in safety reporting sections of protocols vs protocol template; review and implement protocol specific reporting requirement e.g for Adverse Events of Special Interest; and ensure corresponding database and reporting processes are in place (e.g. IMP designation, appropriate listing of protocol in ARISg).
- Contributes to safety reporting sections of periodic reports (e.g. IND Annual Report, DSUR).
- Proactively interface with gRED Protocol Execution Team Leader (PETL/CPET) to identify operational support needs for Safety Management Team (SMT) and/or Protocol Execution Team (PET/CPET) and prioritize coverage as needed.
- Coordinate with PETLs/CPETLs to provide support to CRO regarding scope of work, requests for proposals, safety management plans, and kick-off activities.
- Coordinate SDEA process to ensure liaison between PET, PDSO representatives, and DSL members.
- Provide general assistance and expert input to the LEAD-gRED team members with the PDSS-PDSO interface.
- Expected to play an advanced, expert role in PDS's/PDSS's policies, procedures, processes and other infrastructure developments.
Please be in contact for this position ASAP!
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