Responsible for preparation and submission of required regulatory documents such as CV’s, Laboratory Certificates, FDA Forms including FDA IND, 1572’s, financial disclosure forms, training certificates, delegation of authority forms, Pharmacy logs, IRB approvals, and misc. paperwork required for study compliance to study sponsor for each research protocol.
Prepare and submit to IRB study documents such as study protocols, Investigator Brochures, ICFs, monitor/DSMB reports, and applicable safety reports.
Prepare and submit to IRB all updated study documents as they become available.
Respond to IRB and sponsor questions. Change the Inform Consent based on collaboration with the sponsor and IRB. Resubmit the requested changes to the committees in a timely manner.
Maintain close communication with Principal Investigator and study team regarding status of regulatory documents and sponsor approvals for study documents.
Review all study protocols, Investigator Brochures, and applicable safety reports with the Principal Investigator and all study personnel.
Document all communications with study sponsors.
Review study budgets based on protocol procedures to delineate standard of care vs. study driven procedures.
Submit appropriate budget price requests to UCLA ancillary department in order to obtain current research prices.
Set up accounts for radiology, pharmacy, CTRC, ECG, and UCLA labs.
Submit sponsor approved study budget to UCLA budget committee. Initiate and participate in budget negotiations with study sponsors as appropriate. Implement changes to the study budget in order to produce a final approved study budget.
Communicate directly with fund manager, and contracts and grants office once the final budget is approved. Submit protocol, final budget, contract documents and necessary paperwork per policy.
Maintain all study required regulatory documents for accuracy and completeness.
Prepare and submit study procedures cost invoices to study sponsors.
Maintain accurate records of all invoices and study procedure costs
Review, track, and submit serious adverse events that occur at UCLA for review by the study sponsor, IRB and ISPRC/DSMB (when necessary).
Prepare and submit annual study renewal to IRB in a timely manner.
Prepare and submit final study closure notifications to appropriate committees such as IRB and contracts and grants.
Job Type: Contract
Pay: $22.00 - $25.00 per hour
Benefits:
Schedule:
Experience:
Work Location: Hybrid remote in Los Angeles, CA 90024
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