Clinical Research Associate Role
Job Description:
We are seeking a highly skilled Clinical Research Associate to join our team. The successful candidate will be responsible for the feasibility, initiation, monitoring, and close-out of investigative sites.
Responsibilities:
1. Conduct site qualification visits, collect and review site regulatory documents, and prepare site qualification visit reports.
2. Train site personnel on Client and regulatory requirements for study conduct.
3. Conduct site monitoring visits to ensure that all clinical aspects of studies are being carried out in accordance with study plans, GCPs, and applicable regulations.
4. Analyze on-site files and records for completeness accuracy consistency compliance initiate corrective action as required assist submissions Independent Ethics Committees central local Competent / Regulatory Authorities arrange payments facilitate budgets contracts requested train staff within reasonable period current document protocol deviations appropriately documented followed completion manage visit schedule ongoing regular communication between teams maintain contact staff patient enrollment patients status IP supply further requests issues ensure essential documents filed according project guidelines transmission data management reviews queries clarifies obtains changes appropriate timely transmission conducts closing out final IP reconciliation disposition completes closes files retrieval documents TMF prepares closing visit associated documentation attends meetings participates User Acceptance Testing if necessary assists development implementation specific procedures methods guidelines tools participate participant tracking systems monitor assessment troubled rescue perform audit preparation direction Clinical Trial Management Senior CRA assigned projects oversees work designated CRAs reviews approves monitoring visit manages schedules provides feedback during annual review process performance assigns Senior dedicated support existing existing resources knowledge operational processes solutions industry senior expert coordinator general leads research associates everyday activities front-end managing organizational critical managers middle job actions duties persons change strategies functions,