Full-Time In-House Clinical Research Associate
Office Based in Newport Beach CA.

PURPOSE: To provide in-house management support for Clinical Projects

RESPONSIBILITIES and Primary Tasks:
- To be fully aware of study requirements
- Familiarization with study protocol
- Attendance at clinical project team set up meetings
- Attendance at Investigator meetings, where appropriate
- Understanding administrative scope of work
- Selection of study sites
- Search Investigator databases to identify potential investigators
- Submission of regulatory applications
- Eestablish list of required regulatory documents and establish/manage formal tracking system
- Manage clinical trial supplies and maintain documentation throughout Organization of Investigator meetings
- Prepare Investigator Site Files, Financial Agreements and other essential documents required for initiation of the site
- Oversee the Regional CRAs tasks of monitoring of the Study including tracking of lab supplies, sample shipments, CRF delivery, data collection tracking, and investigator payments
- Receive phone calls from sites, answer queries, redirect calls or otherwise respond appropriately
- Update tracking system appropriately
- Participate in regular team meetings/teleconference to centrally co-ordinate and archive the clinical study documents
- Set up the in- house Central Study Files, Manage the receipt, copying and filing of clinical documents
- Co-ordinate retrieval of clinical documents to assist with audits
- Make arrangements for archiving the clinical documentation at the end of the study

QUALIFICATIONS:
Bachelors Degree, or above

EXPERIENCE:
1 year or above in a CRO or biopharmaceuticals position.

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