CLINICAL RESEARCH ASSOCIATE Resume

SUMMARY:

Seeking a CRA position where I can effectively contribute to the growth of the company and the drug development process in general.

PROFESSIONAL EXPERIENCE:

CLINICAL RESEARCH ASSOCIATE

Confidential

Responsibilities:

Conduct PSVs, SIVs, MVs and COVs and ensure trip reports are completed in a timely fashion
Identify issues that may impact on the conduct of the study and ensure appropriate closure of all issues
Proactively manage a greater investigator site workload commensurate with experience so that studies are run efficiently and key study objectives are met
Ensure studies are run in line with ICH/GCP, local laws and Sponsor SOPs and procedures
Ensure patient safety is maintained and all safety issues are reported correctly according to all relevant local and international regulatory requirements
Inform the PI and site staff of all issues
Agree and develop corrective and preventative actions with PI and site personnel to close all open issues
Responsible for all aspects of site management from collaboration on site selection to study closeout
Train site staff on the protocol, protocol amendments and Sponsor processes
Understand the product, the protocol and the therapy area in sufficient detail to be able to have appropriate discussions with the investigator team
Interact with health care professionals in a manner which enhances Sponsor’s credibility with the customer
Responsible for managing investigator payments through the system
Ensure that data monitored meets target quality standards
Ensure that data is entered into Sponsor systems in a timely manner
Report on progress of all studies at the investigational site after each visit to ensure that all relevant personnel are aware of progress against plan and any issues that have occurred
Ensure all issues are correctly identified and catalogued
Proactively manage issues to appropriate closure
Maintain accurate site - level information on corporate clinical trials registry
Obtain critical information to enable generation of IIP documentation
Assist in gathering IIP documentation where required to ensure timely site set up
Ensure TMF is complete and accurate QC relevant documents are in TMF in a timely manner

CLINICAL RESEARCH ASSISTANT

Confidential

Responsibilities:

Responsible for coordinating and verification of all in - house documents generated by study sites, monitors and other related sources involved in clinical research projects in the US Reviewing of study and research documents for completeness and accuracy
Serving as a point of contact for field based monitors and study sites
Tracking of study documents
Assist in the planning and organizing of investigator meetings and s
Proactively identify study related issues that arise from time to time and provide recommendations for resolution
In-house tracking of activities at study sites to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures ( SOP) and all study protocols
Collect, review and process regulatory documents from investigator sites
Help CRAs review site documents and correct any inaccuracies before input into the management database
Participate in projects team meetings
Prepare all site documents and visit reports for filing in the Trial Master File
Assist in other areas of clinical study projects as may be assigned

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