2018-10-29

Associate, Clinical Trial Management
Job Opportunity at MEIRxRS / Med Exec Intl

Posted on Oct 29

https://meirxrs.com    818-247-1368

Location: Irvine, CA
Job Type: Contract
Job ID: W4164827

The Associate will be responsible for supporting CTM/OSL and ensuring that all assigned clinical study(ies) are running on time and on budget and are completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures.

Requirements:

Bachelor’s degree or higher (science degree preferably in science or health-related field)
Previous experience of working on a clinical study 
1-2 year relevant experience in pharmaceutical industry or CRO 
Experience supporting clinical trials preferred 
Basic knowledge of drug development and FDA GCP/ICH regulatory guidelines is a plus 
Experience using electronic data capture (EDC) systems is a plus  
Ophthalmology area experience preferred 

Responsibilities: 

Support study feasibility activities and perform database/web searches for sites as needed
Work closely with the Site Start Up (SSU) and ensure all study related regulatory and financial documents are collected and reviewed in support of study activation
Organize and maintain project working files and track critical documents
Reconcile and transmit all essential documentation 
Manage calendars and appointments. Resolve scheduling conflicts as needed. 
Manage and coordinate travel requirements for group, consultants, and partners. 
Prepare and oversee expense account reporting. May contribute to tracking budgets as needed.
Ensure all documents are appropriately filed in the TMF 

Must be eligible to work in the US
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