Vacancy Description
The Position
The Clinical Research Associate (CRA) provides support to Study Lead(s) in clinical study planning, execution and management. The primary purpose of the position is to support the COM/Study Lead in study set-up, execution, oversight, and closeout activities in compliance with the clinical protocol, regulatory requirements, ICH GCP guidelines and governing policies & procedures.
Must be onsite/San Diego - NEED CRA Certification
Responsibilities
Support assigned study teams with TMF set-up, maintenance, ongoing quality control reviews, and final reconciliation of study documents
The Clinical Research Associate (CRA) provides support to Study Lead(s) in clinical study planning, execution and management. The primary purpose of the position is to support the COM/Study Lead in study set-up, execution, oversight, and closeout activities in compliance with the clinical protocol, regulatory requirements, ICH GCP guidelines and governing policies & procedures.
Must be onsite/San Diego - NEED CRA Certification
Responsibilities
Support assigned study teams with TMF set-up, maintenance, ongoing quality control reviews, and final reconciliation of study documents
- Routinely monitor TMF inspection readiness for assigned studies
- Assist Study Lead with investigational product and ancillary supplies management, accountability and reconciliation activities
- Collect and/or review Essential Documents from investigational sites
- Review informed consent documents for accuracy and completeness <...
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